obelis logo

Obelis European Authorized Representative Center

"CE Marking Consultants with a Reputation for Excellence"


You are here:
Obelis News:

Compliance with the EMC Directive 2004/108/EC

Repealed MSD 98/37/EC

Compliance with MSD 2006/42/EC

Scope of MSD 2006/42/EC

Structure of the MSD 2006/42/EC

Repealed Directive – TSD 88/378/EEC

Compliance with the TSD 2009/48/EC

Scope of the TSD 2009/48/EC

Structure of the TSD 2009/48/EC

Repealed CPD 89/106/EEC

Compliance with the CPR 305/2011/EU

Scope of the CPR 305/2011/EU

Structure of the CPR 305/2011/EU

Compliance with the ATEX 94/9/EC Directive

Scope of ATEX 94/9/EC Directive

Structure of the ATEX 94/9/EC Directive

Compliance with the MVD 2007/46/EC

Scope of the MVD 2007/46/EC

Structure of Directive 2007/46/EC

Kits: Systems and Procedure packs

Custom made devices

The 1223/2009/EC

Registration Procedures

The Directive

Compliance with the AIMDD-90-385-EEC

Scope of the AIMDD-90-385-EEC

Structrure of the AIMDD-90-385-eec

Compliance with the CE Marking Directive

Scope of the CE Marking Directive

Structure of the CE Marking Directive

Process for compliance with Obelis

Process for compliance with Obelis

Notification Procedure for Clincial Investigation

Notification Procedure for Class I Devices

Scope of the PED 97/23/EC

Structure of the PED 97/23/EC

Compliance with the PED 97/23/EC

Compliance with the R&TTE Directive 1999/5/EC

Structure of the R&TTE Directive 1999/5/EC

Scope of the MDD 93/42/EEC

Compliance with the PPE Directive 89/686/EEC

Scope of the PPE Directive 89/686/EEC

Structure of the PPE Directive 89/686/EEC

Scope of the GPSD 2001/95/EC

Compliance with the GPSD 2001/95/EC

Structure of the GPSD 2001/95/EC

Scope of the LVD 2006/95/EEC

Structure of the LVD 2006/95/EEC

Compliance with the LVD 2006/95/EEC

Scope of the EMC Directive 2004/108/EC

Structure of the EMC Directive 2004/108/EC

Scope of the IVDD 98/79/EC

Compliance with the IVDD 98/79/EC

Structure of the IVDD 98/79/EC

Amendment 2006/42/EC

Scope of the Cosmetics Directive 76/768/EEC

Structure of the Cosmetics Directive 76/768/EEC

Compliance with the Cosmetics Directive 76/768/EEC

Amendment 2007/47/EC

Clinical Investigation of the MDD 93/42/EEC (Annex X)

Compliance with the MDD 93/42/EEC

Structure of the MDD 93/42/EEC

When complying with this directive, products need to comply with the protection requirements according to Annex I of the EMC Directive. Compliance with these protection requirements is demonstrated by applying the conformity assessment procedure detailed in Annex II or Annex III of the directive. Technical documentation must be prepared to demonstrate evidence of compliance with the protection requirements. EMC assessment of products must be performed in order to demonstrate that it meets the protection requirements. All measures necessary must be taken to show that electrical equipment is manufactured in accordance with the technical documentation. EC Declaration of Conformity must be completed and affix the CE marking. You may opt on a voluntary basis to involve a Notified Body during the conformity assessment procedure to review your Technical Documentation.

Protection requirements for all equipment

Equipment shall be so designed and manufactured as to ensure that:
• The electromagnetic disturbance generated does not exceed the level above which radio and telecommunications equipment or other equipment cannot operate as intended
• It has a level of immunity to the electromagnetic disturbance to be expected in its intended use which allows it to operate without unacceptable degradation of its intended use

Specific requirements for fixed installations

Fixed installations shall be installed applying good engineering practices and respecting the information on the intended use of its components.

For non-EU manufacturers: Appoint a European Authorized Representative established within the European Community.

Non-Compliance

The directive portrays European Law enforced within the European Economic Area (EEA); non-compliance with the directive’s requirements will result in the removal of the apparatus from the market and the revoking of the CE marking affixed on the apparatus.

EMC 2004/108/EC | Structure | Scope | Compliance | EMC 2004/108/EC Services

The repealed Machinery Directive 98/37/EC provisions’ are the core of the revised Machinery Directive 2006/42/EC which aims at consolidating the achievements of the Machinery Directive in terms of free circulation and safety of machinery while improving its application.

One of the most important aspects of the Directive, compliance wise, is the “CE” affix which on a product represents the manufacturer’s claim that the machine meets the essential health and safety requirements (ESHR’s) of the Machinery Directive (may also include the Low Voltage Directive, EMC Directive, Pressure Directive, etc.). The ESHR’s for machinery take into account potential dangers to operators and other persons using or affected by the machine. ESHR’s include, materials used in the construction; lighting; controls; stability; fire; noise; vibration; radiation; emission of dust, gasses etc.; maintenance and documentation. Compliance with the appropriate Harmonized European Standards (“Euro Norms” or EN’s) is recognized as meeting with the appropriate ESHR’s.

Before a product is placed on the market the following must happen:
  • The manufacturer must put together a Technical Construction File, a document which makes it possible to assess whether the product complies with the directive;
  • The manufacturer or the authorized representative must draw up a “Declaration of Conformity” (or for partially completed equipment, a “Declaration of Incorporation”);
  • The manufacturer or the authorized representative must affix the CE marking.

For non-EU manufacturers: Appoint a European Authorized Representative established within the European Community.

Non-Compliance

The directive portrays European Law enforced within the European Economic Area (EEA); non-compliance with the directive’s requirements will result in the removal of the product from the EEA and the revoking of the CE marking affixed on the machinery.



Contact us for additional information or Get a Quote!

MSD 2006/42/EC | Structure | Scope | Compliance | Repealed Directive – MSD 98/37/EC | MSD 98/37/EC Services

This new Directive 2006/42/EC makes key changes to the Declaration of Conformity. The person who is authorized to compile the Technical File must be established in the European Community. Where appropriate, there must be a statement confirming Declaration of Conformity with other applicable directives. And there is no longer a separate declaration for safety components, and the declaration must be typewritten or handwritten in capital letters.

There are also significant additions and changes to the essential health and safety requirements (EHSRs) that will affect machine design, including requirements for guarding and control systems. Some of the safety devices that fall under the scope of the Directive include, as already mentioned, control devices for calling lifting appliances and anti-fall devices for hoists, plus monitoring devices for loading and movement control in lifting machinery – as well as solenoid valves controlling dangerous movements of machinery.

Control systems, says the Directive, must be designed and constructed in a way that will prevent a hazardous situation arising. Manual controls must be clearly visible and identifiable, and the use of pictograms is recommended. And an operator must, from each control position, be able to ensure that no one is in the danger zone – even if that means that the machinery can be controlled only from positions in one or more predetermined zones or locations.

Starting is covered as well; the Directive states that it must be possible to start machinery only by the voluntary action of a manual control provided for that purpose. The restarting of a machine or a change in operating conditions may however be effected by the voluntary action of a device other than the manual control provided for that purpose, unless this would lead to a dangerous situation. There are obviously many more issues contained within the new Machinery Directive, and it is vital that business organizations move in good time to make sure that they comply. But it is worth underlining here that in terms of control integrity, there are other European Standards in force that are also relevant.

EN 954-1 Safety of Machinery – Safety Related Parts of Control Systems, the standard that previously applied to all safety-related parts of control systems will be replaced by two standards that co-exist. The original standard will remain valid until November 2011 to provide a period of transition to the new version. People that design and install electronic safety systems can choose between the requirements of either EN ISO 13849-1 or EN/IEC 62061, and still fully comply with the European Machinery Directive.

In general terms, EN ISO 13849-1 takes a four-stage approach to the design of safety-related control systems:

  • Perform a risk assessment (EN ISO 14121);
  • For the identified risks, allocate the safety measure (Performance Level or PL);
  • Devise a system architecture that is suitable for the PL;
  • Validate the design to check that it meets the requirements of the initial risk assessment.

For further details on the new 2006/42/EC Directive, please consult Structure of Directive, Scope of Directive, Legislation page or Obelis’ services page.



Contact us for additional information or Get a Quote!

MSD 2006/42/EC | Structure | Scope | Compliance | Repealed Directive – MSD 98/37/EC | MSD 98/37/EC Services

The MSD 2006/42/EC Directive applies to all machinery and to safety components. A machine is defined as "an assembly ... of linked parts or components, at least one of which moves...”. Clearly this definition encompasses a very large range of machines, from simple hand-held power tools through to complete automated industrial production lines.

There are some exclusions from the Directive - for example motor vehicles used on public roads (which are covered by Directive MVD 2007/46/EC), weapons and machines which are already covered by other, more specific, directives (e.g. lifts and toys – which are covered by TSD 2009/48/EC). It is also possible for the Machinery Directive to apply alongside other directives when there are hazards which the more specific directive does not fully cover, for example the lifting function of medical devices used to move patients. Certain specific types of equipment which fit the definition of machinery but are also within the scope of the Low Voltage Directive are also excluded from the Machinery Directive on the grounds that the risks they present are mainly electrical in nature. These include “ordinary office machinery” and “household appliances for domestic use”.

Secondhand machinery which was first used within the European Economic Area prior to the date of the implementation of the old directive (i.e. before 1 January 1995) is excluded from having to comply with new Directive. However, if that machinery is refurbished or upgraded so that its original specification is changed, it will have to be made to comply with the full requirements of the Directive.

Any machinery which was manufactured before 1 January 1995 must be made to comply with the directive if it subsequently brought into Europe from outside just as would any newer machinery manufactured outside the EU.

Equipment manufactured for the manufacturer's own use is not excluded from the requirements, but may be subject to slightly lesser obligations with respect to marking and documentation.

In addition to the products within the scope of MSD 98/37/EC, MSD 2006/42/EC now also includes the following products:

  • Escalators and mechanical walkways;
  • Construction-site hoists;
  • Elevators with max. = 0,15 m/s2;
  • Partly completed machinery;
  • Lifting accessories (chains, ropes and webbing);
  • Stage elevators (not for persons);
  • Road vehicles with max. 25 km/h;
  • Removable mechanical-transmission devices;
  • Two/three-wheel motor vehicles with max. 6 km/h.

For further details on the new 2006/42/EC Directive, please consult Structure of Directive, Compliance with the Directive, Legislation page or Obelis’ services page.



Contact us for additional information or Get a Quote!

MSD 2006/42/EC | Structure | Scope | Compliance | Repealed Directive – MSD 98/37/EC | MSD 98/37/EC Services The Machine Safety Directive (May 17 2006), unlike the previous version which it repealed, has not granted any transition period for compliance. The Directive is structured in the following manner: 29 articles and 12 annexes.
  • Article 1: Scope;
  • Article 2: Definition;
  • Article 3: Specific Directives;
  • Article 4: Market Surveillance;
  • Article 5: Placing on the Market and putting into service;
  • Article 6: Freedom of Movement;
  • Article 7: Presumption of Conformity and harmonized standards;
  • Article 8: Specific Measures;
  • Article 9: Specific measures to deal with potentially hazardous machinery;
  • Article 10: Procedure for disputing a harmonized standard;
  • Article 11: Safeguard Clause;
  • Article 12: Procedures for assessing the conformity of a machinery;
  • Article 13: Procedure for partially completed machinery;
  • Article 14: Notified Bodies;
  • Article 15: Installation and use of machinery;
  • Article 16: CE-marking;
  • Article 17: Non-conformity of marking;
  • Article 18: Confidentiality;
  • Article 19: Cooperation between Member States;
  • Article 20: Legal remedies;
  • Article 21: Dissemination of information;
  • Article 22: Committee;
  • Article 23: Penalties;
  • Article 24: Amendment of Directive 95/16/EC;
  • Article 25: Repeal;
  • Article 26: Transposition;
  • Article 27: Derogation;
  • Article 28: Entry into force;
  • Article 29: Addressees.
  • Annex I: Essential Health and Safety requirements relating to the design and construction of machinery;
  • Annex II: Declarations;
  • Annex III: CE Marking;
  • Annex IV: Categories of machinery to which one of the procedures referred to in article 12(3) and (4) must be applied;
  • Annex V: Indicative list of safety of safety components referred to in article 2(c);
  • Annex VI: Assembly instructions for partly completed machinery;
  • Annex VII: Technical file for Machinery/relevant technical documentation for partly completed machinery;
  • Annex VIII: Assessment of Conformity with internal checks on the manufacture of machinery;
  • Annex IX: EC-type examination;
  • Annex X: Full quality assurance;
  • Annex XI: Minimum criteria to be taken into account by Member states for the notification of bodies;
  • Annex XII: Correlation table.
For further details on the new 2006/42/EC Directive, please consult Scope of Directive, Compliance with the Directive, Legislation page or Obelis’ services page.

Contact us for additional information or Get a Quote!

MSD 2006/42/EC | Structure | Scope | Compliance | Repealed Directive – MSD 98/37/EC | MSD 98/37/EC Services The general provisions of TSD 2009/48/EC are applicable to toys placed on the market as of 20 July 2011. However, TSD 88/378/EEC remains applicable to toys placed on the market before this date. During the transitional period of TSD 2009/48/EC, chemical requirements under TSD 88/378 remain applicable to toys placed on the market as before 20 July 2013 as well. Directive 88/378/EEC was initially adopted in the context of the achievement of the internal market in order to avoid barriers to trade originated by different safety provisions applied by Member States. The Directive also had the aim to reach a high level of toy safety in the Community. However, the technological developments in the toys market raised new issues regarding the safety of toys. The new Directive answers to the need of updating the existing safety requirements of providing a more coherent approach in the implementation of market surveillance. TSD 88/378/EEC defined as a toy: “any product or material designed or clearly intended for use in play by children of less than 14 years of age”. The scope is now broader in Directive 2009/48/EC, which applies to toys defined as "products designed or intended, whether or not exclusively, for use in play by children under 14 years of age". However, apart from differences in scope further comparisons between TSD 88/378/EEC and TSD 2009/48/EC can be done:
  • TSD 2009/48/EC establishes stricter obligations to the importer and to the distributor:
    • Importer: can only place compliant toys on the EU market and needs to ensure that Manufacturer has drawn up the technical documentation; has to ensure that the products bear the CE mark and that the importer’s name and address is indicated;
    • Distributors: must act with due care, while ensuring the presence of the CE mark and of the required documentation.
  • Enhanced safety requirements:
    • In case a risk is not covered by any particular safety requirement:
      • TSD 88/378/EEC - “Users of toys as well as third parties must be protected against health hazards and risk of physical injury when toys are used as intended or in a foreseeable way, bearing in mind the normal behavior of children”;
      • TSD 2009/48/EC - “Toys shall not jeopardize the health or safety of users or third parties when they are used as intended or in a foreseeable way, bearing in mind behavior of children.”
    • Physical and Mechanical Properties – Toys must not present the following risks:
      • Choking risks
        • TSD 88/378/EEC - Toys for children under 36 months;
        • TSD 2009/48/EC - Extended to other toys which are intended to be put in the mouth.
      • Suffocation Risk
        • TSD 88/378/EEC – As a result of external airway obstruction of mouth and nose;
        • TSD 2009/48/EC – As a result of internal airway obstruction.
      • Toys in food
        • TSD 88/378/EEC - No references;
        • TSD 2009/48/EC – a) Toys contained within food or co-mingled with food must have their own packaging. This packaging must be of such dimensions as to prevent its being swallowed and/or inhaled; b) Toys contained in food or co-mingled with food shall bear the following warning: “Toy inside. Adult supervision recommended”; c) Toys firmly attached to a food product at the moment of consumption, in such a way that the food product needs to be consumed in order to get direct access to the toy, shall be prohibited (this is the case of some lollypops).
      • Chemical Properties
        • TSD 88/378/EEC
          • Toys must present no health hazard or risk of physical injury by ingestion, inhalation or contact with the skin, mucous tissues or eyes;
          • Toys must comply with the relevant Community legislation relating to certain categories of products or to the prohibition, restriction of use or labeling of certain dangerous substances and preparations;
          • Definition of maximum levels for cadmium, chromium, lead, mercury, selenium.
        • TSD 2009/48/EC
          • Toys must present no risks of adverse effects on human health due to exposure to the chemical substances or preparations of which toys are composed or which they contain;
          • Compliance with the relevant Community legislation relating to certain categories of products or to the prohibition, restriction of use or labeling of certain dangerous substances and preparations, including REACH (Regulation 1907/2006);
          • Inclusion of three different sets of rules especially for toys:
            • Prohibition of CMR (with the possibility of exemptions);
            • Ban of 38 allergenic fragrances; traces allowed if unavoidable in good manufacturing practice;
            • Stricter limits for certain heavy metals.
      • Electrical Properties
        • TSD 88/378/EEC
          • Toys must not be powered by electricity exceeding 24 Volts;
          • If risk of electrical shock, proper insulation and mechanically protection;
          • Maximum temperatures of exposure may not cause burns.
        • TSD 2009/48/EC – In addition:
          • Toys must provide protection against electrical hazards arising from an electrical power source, against fire hazards;
        • Toys must present no health hazards or risk of injury to eyes or skin from lasers, LED or any other type of radiation.
    • Hygiene
      • TSD 88/378/EEC
        • Toys must meet the requirements of hygiene and cleanliness in order to avoid any risk of infection, sickness and contamination.
      • TSD 2009/48/EC
        • Extension of the above with “Textile toys for children under 36 months shall be washable and need to fulfill the Environmental and Safety Requirements also after washing.
  • Warnings
    • TSD 88/378/EEC
      • Visible and clearly legible warnings.
    • TSD 2009/48/EC
      • Extension of the above with warning must specify if appropriate: a) user limitations; b) ability of the user; c) minimum or maximum weight; d) adult supervision.
  • Conformity Assessment Procedures
    • TSD 88/378/EEC
      • Self verification if - harmonized standard covering all safety aspects are complied with;
      • Third party verification (EC type examination) if: a) harmonized standards do not exist (i.e. magnets); b) harmonized standards are not complied with completely; c) manufacturers consider that toy necessitates third party verification.
    • TSD 2009/48/EC
      • Explicit obligation to carry out an analysis of hazards.
Contact us for additional information or Get a Quote!

TSD 2009/48/EC | Structure | Scope | Compliance | Repealed Directive – TSD 88/378/EEC | TSD 88/378/EEC & 2009/48/EC Services Only toys meeting the essential requirements of TSD 2009/48/EC may be placed in the EEA market and entitled to free movement throughout all Member States. In particular, standards laid down by the European standardization bodies provide evidence of compliance with the essential requirements – toys meeting these requirements bear the CE marking. When a toy is placed on the EEA market, the manufacturer must draw up an EC declaration of conformity, which must be kept by the manufacturer or its authorized representative established within the EU for a period of 10 years after the toy is put on the market and continuously updated if necessary. By doing so, the manufacturer assumes the responsibility for the compliance of the toy with the essential requirements of the TSD 2009/48/EC. Each toy to be placed on the market is subject to a conformity assessment procedure, which demonstrates that a toy placed on the market complies with the requirements of TSD 2009/48/EC. The manufacturer is required to apply one of two possible procedures depending on the nature of the toy:
  • Self verification: used in cases where harmonized standards cover all relevant aspects of a toy. In this case, the manufacturer must apply the existing harmonized standards and ensure that the toy is in conformity. The manufacturer must also put in place an internal production procedure in accordance with Module A of Annex II of Decision 768/2008/EC, for which the involvement of a notified body is not required. However, many large retailers still require an independent report as a condition of supply, even though this is not a legal requirement.
  • Third party verification / “EC-type examination”: it is required in case harmonized standards do not exist; harmonized standards have not or only partly been applied by a manufacturer; one or more harmonized standards have been published with a restriction; or the manufacturer considers that the nature, design, construction or purpose of the toy requires a third party verification.
In such cases, under Module B of Annex II to Decision 768/2008/EC, the manufacturer submits a model of the toy to a notified body which examines the technical design of a toy and verifies and attests that the toy meets the requirements of TSD 2009/48/EC by issuing an EC-type examination certificate. Under Module C, which covers the production phase, the manufacturer ensures the conformity of the toys with the type described in the EC-type examination certificate and with the relevant requirements. Conformity under Module C is evaluated against an approved EC-type examination certificate and does not require the involvement of a notified body.

However, before submitting the toy to the appropriate conformity assessment and before the toy is placed on the market, the manufacturer must draw up a safety assessment, which has the objective of identifying the potential hazards of a toy and to assess the potential exposure to those hazards – this procedure is mandatory under TSD 2009/48/EC and will determine which conformity assessment procedure is required.

The safety assessment must cover the various chemical, physical, mechanical, electrical, flammability, hygienic and radioactivity hazards that the toy may present, as listed in Annex II of TSD 2009/48/EC. Even though many of these requirements are covered by harmonized standards, the manufacturer must assess whether there may be gaps uncovered.

The safety assessment must be kept as well by the manufacturer in the technical documentation for 10 years after the toy has been placed on the market.

For further details on the new 2009/48/EU Directive, please consult Structure of Directive, Scope of Directive, Legislation page or Obelis’ services page.

Contact us for additional information or Get a Quote!

TSD 2009/48/EC | Structure | Scope | Compliance | Repealed Directive – TSD 88/378/EEC | TSD 88/378/EEC & 2009/48/EC Services Directive 2009/48/EC applies to toys defined as "products designed or intended, whether or not exclusively, for use in play by children under 14 years of age". In order to adjust to the current practices of toy manufacturers, the new element of TSD 2009/48/EC is in the wording “whether or not exclusively” of the definition, which indicates that a product does not have to be exclusively intended for playing purposes to be considered a toy. Therefore, products with double functions are also considered as toys. Notwithstanding, the following toys are not included in the scope of TSD 2009/48/EC
  • Playground equipment intended for public use;
  • Automatic playing machines, whether coin operated or not, intended for public use;
  • Toy vehicles equipped with combustion engines;
  • Toy steam engines;
  • Slings and catapults.
Annex I of the TSD also presents a non-exhaustive list of products that are not considered as toys but that could originate confusions, and in which case, other EU Directives such as GPSD (2001/95/EC), MSD (98/37/EC), R&TTE (1999/5/EC), EMC (2004/108/EC) and LVD (2006/95/EC) may be applicable. This is the case of:
  • Decorative objects for festivities and celebrations;
  • Products for collectors, when intended for collectors of 14 years of age and above;
  • Sports equipment intended for children with a body mass of more than 20 kg;
  • Bicycles with a maximum saddle height of more than 435 mm;
  • Scooters and other means of transport intended to be used for travel on public roads or public pathways;
  • Electrically driven vehicles intended to be used for travel on public roads, public pathways, or pavement;
  • Aquatic equipment intended to be used in deep water, and swimming learning devices for children;
  • Puzzles with more than 500 pieces;
  • Guns and pistols using compressed gas;
  • Fireworks;
  • Products and games using sharp-pointed missiles;
  • Functional educational products operated at a nominal voltage exceeding 24 volts which are sold exclusively for teaching purposes under adult supervision;
  • Products intended for use for educational purposes in schools and other pedagogical contexts under the surveillance of an adult instructor;
  • Electronic equipment, such as personal computers and game consoles;
  • Interactive software, intended for leisure and entertainment, such as computer games, and their storage media;
  • Babies’ soothers;
  • Child-appealing luminaries;
  • Electrical transformers for toys;
  • Fashion accessories for children not for use in play.
For further details on the new 2009/48/EC Directive, please consult Structure of Directive, Compliance with the Directive, Legislation page or Obelis’ services page.

Contact us for additional information or Get a Quote!

TSD 2009/48/EC | Structure | Scope | Compliance | Repealed Directive – TSD 88/378/EEC | TSD 88/378/EEC & 2009/48/EC Services The Toy Safety Directive 2009/48/EC contains 57 Articles – divided by 9 chapters - and 5 Annexes. As a point of comparison, the Toy Safety Directive 88/378/EEC has 16 Articles and 4 Annexes. The Articles, divided into 9 chapters, cover general items such as scope and definitions, obligations of Economic operators (Manufacturers, Importers, Authorized Representative and Distributors), conformity with essential safety requirements, reference to harmonized standards, placing products on the market and putting them into service, free movement of CE-marked goods in EU Member States, vigilance and incident reporting, consequences of wrongly affixed CE Marking etc.
  • Chapter I – General Provisions
  • Chapter II – Obligations of Economic Operators
  • Chapter III – Conformity of Toys
  • Chapter IV – Conformity Assessment
  • Chapter V – Notification of Conformity Assessment Bodies
  • Chapter VI – Obligations and Powers of Member States
  • Chapter VII – Committee Procedures
  • Chapter VIII – Specific Administrative Provisions
  • Chapter IX – Final and Transitional Provisions
  • Annex I: contains a list of products that are not considered as toys within the meaning of the Directive
  • Annex II: makes reference to the mandatory safety requirements for toy manufacturers. It includes elements such as: physical and mechanical properties of toys, flammability, chemical properties, electrical properties, hygiene, and radioactivity.
  • Annex III: gives instructions regarding the EC Declaration of Conformity.
  • Annex IV: lists the minimum requirements for the technical documentation.
  • Annex V: provides instructions regarding the general and specific warnings to affix on toys.
For further details on the new 2009/48/EC Directive, please consult Scope of Directive, Compliance with the Directive, Legislation page or Obelis’ services page.

Contact us for additional information or Get a Quote!

TSD 2009/48/EC | Structure | Scope | Compliance | Repealed Directive – TSD 88/378/EEC | TSD 88/378/EEC & 2009/48/EC Services The now repealed Directive of 1988 (CPD 89/106/EEC) was aimed at creating conditions for the competitiveness of the construction and construction products industries. Therefore, the essential requirements regarding safety, public health, protection of citizens, and the environment must be fulfilled. It also provides guidelines for CE Marking affix, vigilance and incident reporting, conformity assessment procedures. The products must be suitable for construction works, thus the requirements for conformity concern actions which can be anticipated, in respect to:
  • Mechanical resistance and stability: The construction works must be developed preventing loadings from collapsing of the entire or a part of the work, major deformations to an inadmissible degree, damage to other parts of the works, damage by an event to an extent disproportionate to the original cause;
  • The products have to be suitable for construction tasks which are fit for their intended use. Thus, requirements refer to normal maintenance and concern actions which are foreseeable;
  • Risk of fire: The construction works must be designed and built in such a way that in case of fire, the load-bearing capacity of the construction can be assumed for a limited period of time, the generation and spread of fire and smoke within the works are limited, the spread of the fire to neighboring construction works is limited, workers can leave the place or be rescued by other means and the safety of rescue teams is taken into account;
  • Environmental, hygienic and health aspects: The construction work should not endanger the hygiene or health of the people. Particularly, the following aspects are considered:
    • The giving-off of toxic gas
    • The presence of dangerous particles or gases in the air
    • The emission of dangerous radiation
    • Pollution or poisoning of the water or soil
    • Faulty elimination of waste water, smoke, solid or liquid wastes
    • Presence of damp parts of the works or on surfaces within the works
  • Safe use: The construction works must be designed and built without presenting unacceptable hazard of accidents in service like slipping, falling, collision, burns, electrocution, injury from explosion;
  • Protection against noise: The construction works must be designed and built in such a way that noise will not endanger health of people and will allow them to sleep, rest and work in correct conditions;
  • Energy economy and heat retention: The construction works and its heating, cooling and ventilation installations must be designed and built seeking not to save energy respecting the climatic conditions of the place and the occupants.
Attestation of Conformity

The manufacturer or his European Authorized Representative, are responsible for the attestation that products are in conformity with the requirements of a technical specification (Standards and technical approvals). Products that are subject to an attestation of conformity will benefit from the presumption of conformity, with technical specifications (standards and technical approvals). Conformity will be set up through testing or other evidence based on the technical specifications. The conformity of a product is dependent on the manufacturer (who has a factory production control system to guarantee that production is compliant with the relevant technical specifications). In this case, a Declaration of Conformity for a product needs to be provided by the manufacturer, or his agent established on the European Economic Area.
The procedure for a specific product or a set of products will be determined by the Commission after consultation of the committee, according to:
  • The importance of the part played by the product in relation to the essential requirements, particularly those requirements in connection with health and safety;
  • The nature of the product;
  • The effect of the variability of the product’s characteristics and the possibility of having defects in the product’s manufacture.
The cheapest procedure consistent with safety will be the chosen one.

Conformity Control’s Methods

When the procedures for attestation of conformity of a product with technical specifications are determined, the following methods of control of conformity will be used. The chosen method depends on the criteria given above.
  • Initial test done by the manufacturer or an approved body which determines the type of product;
  • Testing of samples taken at the factory according to an already-defined test plan by the manufacturer or an approved body;
  • Audit-testing of samples taken at the factory, on the open market or on a construction site by the manufacturer or an approved body;
  • Testing of samples from a batch which is ready for delivery, or has been delivered, by the manufacturer or an approved body;
  • Factory production control, inspection of factory and factory production control by an approved body;
  • Continuous surveillance, judgment and evaluation of factory production control by an approved body.
Conformity Attestation’s Systems

Certification of the conformity of the product by an approved certification body based on:
  • Manufacturer: Factory production control and testing of samples from the factory
  • Approved body: An initial type-testing of the product, inspection of the factory, continuous surveillance, evaluation and approval of factory production control and possible audit-testing of samples from the factory
Declaration of conformity of the product by the manufacturer based on:
  • Manufacturer: initial test to determine the type of the product, factory production control, possible testing of samples from the factory
  • Approved body: Certification of factory production control
The manufacturer’s declaration of conformity or the certificate of conformity will give right to the manufacturer, or his representative established in the EEA, to affix the pertinent CE Marking on the product, on a label attached to it, on its packaging or on the accompanying commercial documents. For non-EU manufacturers, it is compulsory to appoint a European Authorized Representative established within the European Community.

Non-Compliance

The directive portrays European Law in forced within the EEA; non-compliance with the directive’s requirements will result in the removal of the product from the market and the revoking of the CE marking affixed on the product.

Contact us for additional information or Get a Quote!

CPR 305/2011/EU | Structure | Scope | Compliance | Repealed Directive – CPD 89/106/EEC | CPR 305/2011/EU Services Basic Requirements of a Construction Work As specified in Annex I of the regulation, there are seven basic requirements for construction works:
  • Mechanical Resistance and Stability: Construction works must be constructed in a way to maintain stability. The works must not pose a risk of collapsing or causing major deformations that would compromise other parts of the work.
  • Safety in Case of Fire: The construction work must be able to sustain itself for a reasonable amount of time in case of fire, be able to contain the fire as much as possible, and to limit spread of a fire from other works. Occupants must be able to leave the construction works or be safely rescued.
  • Hygiene, Health, and the Environment: Construction works must not pose a risk in the following ways: the release of toxic gases; emissions of dangerous substances into air or water; the release of radiation.
  • Safety and Accessibility in Use: Construction works must not pose an unreasonable risk to such incidents including slipping, falling, collisions, burns, electrocution, explosions, and burglaries. Construction works must be accessible to people with physical disabilities.
  • Protection against Noise: Construction works must be built in a way that limits noise for occupants. Noise levels must maintain a level that is not harmful to the health or safety of occupants. Occupants must be able to sleep, rest, and work in satisfactory conditions.
  • Energy Economy and Heat Retention: Construction works shall be built in a way that minimizes heating, cooling, lighting, and ventilation, while maintaining comfort and safety of occupants. Construction works shall be designed and built to enable energy-efficiency.
  • Sustainable use of natural resources: Construction works must be made with natural resource conservation in mind. Products should be able to be reused or recycled after the demolition of a construction work. The works must be durable and use environmentally friendly raw and secondary materials.

Compliance Testing
For products which are low-risk or custom-made, a simplified procedure has been developed. The new procedure assumes that testing has already been completed, and as such, testing does not need to be redone. “Specific Technical Documentation” (STD), or the test results from similar products, is to be submitted with a manufacturer’s justification for the use of the STD.
For most construction products, harmonized standards will exist and conformity will be based on conformity to these standards. The standards shall all have specific directions instructing manufacturers on which tests shall be performed by the manufacturer itself and which tasks must be completed by a notified body. In some cases, notified body intervention is mandatory, whereas in other cases, it is not necessary and the manufacturer can complete product testing itself.

Technical assessment bodies (TABS) are required for products which do not already fall into pre-existing standards or only partially fall into the scope of a standard. The manufacturer must appoint a TAB, provide information regarding the product. Then the TAB shall draft an assessment document (EAD), have the EAD submitted to the EU authorities. The product must then be assessed for performance of according to the conditions in the EAD.

Declaration of Performance Manufacturers must draft an official document proving conformance with the following standards. This declaration shall put all responsibility for conformity on the manufacturer. The declaration of performance will include detailed information about the product including information about the manufacturer and a href="http://www.obelis.net//" title=' European Authorized Representative'> European Authorized Representative. Information regarding the method of compliance testing will be mandatory beginning July 2013. CE marking shall not be applied to a product until after all testing and drafting of the declaration of performance has been completed.

Non-Compliance Any construction product found to be non-compliant with the regulation shall have its’ CE mark revoked and be taken off of the European market.

For further details on the new CPR 305/2011/EU Directive, please consult Structure of Directive, Scope of Directive, Legislation page or Obelis’ services page.

Contact us for additional information or Get a Quote!

CPR 305/2011/EU | Structure | Scope | Compliance | Repealed Directive – CPD 89/106/EEC | CPR 305/2011/EU Services As stated in the regulation in Article 2 of CPR 305/2011/EU, a construction product is defined as any product that is to be permanently placed into a construction work (building construction or civil engineering) which has an effect on the performance of the construction work. The product can be in the form of a single product or a kit of products meant to be used in unison. There are 35 areas of classification for a construction work. All products are to be classified into one of the classifications and tested based on the requirements of each classification. The product must comply with the essential characteristics of a construction product.

For further details on the new CPR 305/2011/EU Directive, please consult Structure of Directive, Compliance with the Directive, Legislation page or Obelis’ services page.

Contact us for additional information or Get a Quote!

CPR 305/2011/EU | Structure | Scope | Compliance | Repealed Directive – CPD 89/106/EEC | CPR 305/2011/EU Services The Construction Products Regulation consists of 9 chapters, 68 articles, and 5 annexes. The chapters and articles contain basic information regarding the regulation including: basic requirements, required declarations, CE marking information, obligations of involved parties, technical specifications and assessment, technical documentation, notified bodies and authorities information, market surveillance, and consumer safeguards. The annexes contain more specific information and requirements as outlined below.
  • Annex I: Basic Requirements for Construction Works
  • Annex II: Procedure for Adopting a European Assessment Document
  • Annex III: Template for Declaration of Performance
  • Annex IV: Table of Product Areas (Classifications) and Requirements for TABS
  • Annex V: Assessment and Verification of Constancy of Performance
For further details on the new CPR 305/2011/EU Directive, please consult Scope of Directive, Compliance with the Directive, Legislation page or Obelis’ services page.

Contact us for additional information or Get a Quote!

CPR 305/2011/EU | Structure | Scope | Compliance | Repealed Directive – CPD 89/106/EEC | CPR 305/2011/EU Services Only equipment and protective systems complying with Directive 94/9/EC and bearing the CE marking, which must be visibly affixed, may move freely throughout the European Union market.

Once the manufacturer has undertaken the appropriate procedures to assure conformity with the essential requirements of the Directive it is the responsibility of the manufacturer or his authorized representative established in the EU not only to affix the CE marking, but also to draw up a written EC Declaration of Conformity, and keep a copy within the EU for a period of ten years after the last equipment has been manufactured.

According to the Directive, in order to determine the appropriate conformity assessment procedure, the manufacturer must base the decision on the intended use of the product to identify as to which Group and Category it belongs:

Group I includes equipment intended for use in the underground parts of mines, and to those parts of surface installations of such mines, likely to become endangered by firedamp and/or combustible dust;

  • Category M1: Products required to remain functional for safety reasons when an explosive atmosphere is present and characterized by integrated explosion protection measures functioning in such a way that: a) in the event of failure of one integrated measure, at least a second means of protection provides for a sufficient level of safety; or, b) in the event of two faults occurring independently of each other, a sufficient level of safety is ensured.
  • Category M2: Products intended to be de-energized in the event of an explosive atmosphere. The protection measures relating to products of this Category provide a sufficient level of safety during normal operation even in the event of more severe operating conditions arising, from rough handling and changing environmental conditions.

  • Group II includes equipment intended for use in other places likely to become endangered by explosive atmospheres;
  • Category 1: products designed to be capable of remaining within its operational parameters, stated by the manufacturer, and ensuring a very high level of protection for its intended use in areas in which explosive atmospheres caused by mixtures of air and gases, vapors, mists or air/dusts mixtures are highly likely to occur and are present continuously, for long periods of time or frequently.
  • Equipment of this Category is characterized by integrated explosion protection measures functioning in such a way that: a) in the event of a failure of one integrated measure, at least a second independent means of protection provides for a sufficient level of safety; or, b) in the event of two faults occurring independently of each other a sufficient level of safety is ensured.
  • Category 2 comprises products designed to be capable of remaining within their operational parameters, stated by the manufacturer, and based on a high level of protection for their intended use, in areas in which explosive atmospheres caused by mixtures of air and gases, vapors, mists or air/dust mixtures are likely to occur.
  • The explosion protection relating to this Category must function in such a way as to provide a sufficient level of safety even in the event of equipment with operating faults or in dangerous operating conditions which normally have to be taken into account.
  • Category 3 comprises products designed to be capable of keeping within its operational parameters, stated by the manufacturer, and based upon a normal level of protection for its intended use considering areas in which explosive atmospheres caused by mixtures of air and gases, vapors, mists or air/dust mixtures are unlikely to occur and if they do occur, do so infrequently and for a short period of time only.
The design of the products of this category must provide a sufficient level of safety during normal operation.

 

After identifying to which Group and Category the product belongs, the appropriate conformity assessment procedure must be adopted:
  • EC Type Examination:
  • - Provides a specimen of the envisaged production to a Notified Body which undertakes the necessary evaluation to determine that the "type" meets the essential requirements of Directive 94/9/EC and issues an EC Type Examination Certificate (Annex III);
  • Quality Assurance Modules:
  • - Production Quality Assurance (Annex IV): Operates a quality system approved by a Notified Body for production, final equipment inspection and testing and is subject to on-going surveillance - applies to Equipment Categories 1 and M1 and to protective systems;
    - Product Quality Assurance (Annex VII): A quality system approved by a Notified Body for the final inspection and testing of equipment subject to on-going surveillance - applies to electrical equipment and internal combustion engines only, in Equipment Categories 2 and M2.
  • Verification modules:
  • - Product verification (Annex V): Examination and tests by a Notified Body of every product to check the conformity of the equipment, protective system or device with the requirements of Directive 94/9/EC and draw up a certificate of conformity – applies to Equipment Categories 1 and M1 and to the protective systems;
    - Conformity to type (Annex VI): Tests carried out by a manufacturer on each piece of equipment manufactured to check the explosion protection aspects of the design. Carried out under the responsibility of a Notified Body - applies to electrical equipment and internal combustion engines in Equipment Categories 2 and M2;
    - Unit verification (Annex IX): Notified Body examines individual equipment or protective system and carry out tests as defined in the harmonized standards, if they exist, or otherwise in European, international or national standards or conduct equivalent tests to ensure conformity with the relevant requirements of Directive 94/9/EC and draw up a certificate of conformity - may be applied at the option of the manufacturer as an alternative to any other conformity assessment modules.
  • Internal control of production (Annex VIII): Product and quality system assessment procedure carried out by the manufacturer and retention of documentation - applies to equipment in Category 2 and M2 which is not electrical equipment nor internal combustion engines and to equipment Category 3.
For further details on the new 94/9/EC Directive, please consult Structure of Directive, Scope of Directive, Legislation page or Obelis’ services page.

Contact us for additional information or Get a Quote!

ATEX 94/9/EC | Structure | Scope | Compliance | ATEX 94/9/EC Services The general objective of the Directive is to eliminate or at least minimize the risks resulting from the use of certain products in or in relation to a potentially explosive atmosphere, i.e. an atmosphere, which could become explosive due to local and/or operational conditions. In particular, an explosive atmosphere for the purposes of ATEX Directive 94/9/EC is defined as a: Mixture with air, under atmospheric conditions, of flammable substances in the form of gases, vapors, mists or dusts in which, after ignition has occurred, combustion spreads to the entire unburned mixture.
To be within the scope of the ATEX Directive 94/9/EC, a product has to be:
  • An equipment, as defined in Article 1.3.(a) of the Directive : machines, apparatus, fixed or mobile devices, control components and instrumentation thereof and detection or prevention systems which, separately or jointly, are intended for the generation, transfer, storage, measurement, control and conversion of energy and/or the processing of material and which are capable of causing an explosion through their own potential sources of ignition; or
  • A protective system, as defined in Article 1.3.(b) of the Directive : devices other than components of the equipment defined above which are intended to halt incipient explosions immediately and/or to limit the effective range of an explosion and which are separately placed on the market for use as autonomous systems; or
  • A component, as defined in Article 1.3.(c) of the Directive : any item essential to the safe functioning of equipment and protective systems but with no autonomous function; or
  • A safety, controlling or regulating device as defined in Article 1.2. of the Directive : (…) intended for use outside potentially explosive atmospheres but required for or contributing to the safe functioning of equipment and protective systems with respect to the risks of explosion (…).

In addition, a product within the scope of ATEX directive may fall as well within the scope of other directives, which have to be applied in parallel. This may be the case of the following Directives: EMC (2004/108/EC), LVD (2006/95/EC), MSD (98/37/EC), PPE (89/686/EC), PED (97/23/EC) and CPD (89/106/EC).
As per article 1.4 of the Directive the following equipment are not within the scope of the Directive:
  • Medical devices intended for use in a medical environment;
  • Equipment and protective systems where the explosion hazard results exclusively from the presence of explosive substances or unstable chemical substances;
  • Equipment intended for use in domestic and non-commercial environments where potentially explosive atmospheres may only rarely be created, solely as a result of the accidental leakage of fuel gas;
  • Seagoing vessels and mobile offshore units together with equipment on board such vessels or units;
  • Means of transport i.e. vehicles and their trailers intended solely for transporting passengers by air, road, rail or water networks, as well as means of transport in so far as such means are designed for transporting goods by air, by public road or rail networks or by water. Means of transport intended for use in a potentially explosive atmosphere are not excluded;
  • Equipment covered by Article 346 (1)(b) of the Treaty on the Functioning of the EU (TFEU), i.e. designed and manufactured specifically for use by the armed forces or in the maintenance of law and order.

For further details on the new 94/9/EC Directive, please consult Structure of Directive, Compliance with the Directive, Legislation page or Obelis’ services page.

Contact us for additional information or Get a Quote!

ATEX 94/9/EC | Structure | Scope | Compliance | ATEX 94/9/EC Services ATEX Directive 94/9/EC contains 16 Articles divided by 4 chapters - and 11 Annexes as per the list below:
CHAPTER I - Scope, placing on the market and freedom of movement
CHAPTER II - Conformity assessment procedures
CHAPTER III - CE marking conformity
CHAPTER IV - Final provisions

ANNEX I – Criteria determining the classification of equipment groups into categories
ANNEX II - Essential Health and Safety requirements relating to the design and construction of equipment and protective equipment and protective systems intended for use in potentially explosive atmospheres
ANNEX III – Module EC-Type examination
ANNEX IV – Module: Production quality assurance
ANNEX V – Module: Product verification
ANNEX VI – Module: Conformity to type
ANNEX VII – Module: Product quality assurance
ANNEX VIII – Module: Internal control of production
ANNEX IX – Module: Unit verification
ANNEX X – CE Marking and content of the EC declaration of conformity
ANNEX XI – Minimum criteria to be taken into account by Member States for the notification bodies

For further details on the new 94/9/EC Directive, please consult Scope of Directive, Compliance with the Directive, Legislation page or Obelis’ services page.
Contact us for additional information or Get a Quote!

ATEX 94/9/EC | Structure | Scope | Compliance | ATEX 94/9/EC Services Under the new Directive 2007/46/EC the manufacturer is responsible towards the approval authority for all aspects of the approval process and for ensuring conformity of production, whether or not the manufacturer is directly involved in all stages of the construction of a vehicle, system, component or separate technical unit. In the case of multi-stage type-approval, each manufacturer is responsible for the approval and conformity of production of the systems, components or separate technical units added at the stage of vehicle completion handled by him.

The manufacturer who modifies components or systems already approved at earlier stages shall be responsible for the approval and conformity of production of those components and systems.
ECWVTA - European Community Whole Vehicle-Type Approval This is the process by which prototype vehicles are tested to meet European safety and environmental standards defined by various European Directives.

The process includes an assessment of the vehicle production, to ensure that all subsequent vehicles of the specific type, meet the same specification (Homologation ISO 9001 / TS16949). Type approved vehicles are then deemed fit for production and sale within Europe.

Until now, only passenger cars, 2 and 3 wheeled vehicles and agricultural vehicles have been subject to ECWVTC, but over the next few years the process will be extended to cover all passenger and goods vehicles and trailers.

Type Approval Regulations into-force dates for specific vehicles types:

29th October 2010 Minibuses, buses and coaches built in one stage of first stage of a multistage build.
29th October 2011 Light vans and trucks built in one stage or first stage of a multistage build. Minibuses, buses and coaches built in multiple stages.
29th April 2012 Passenger vehicle for “Special purposes” (e.g. motor caravans, ambulances and armored cars).
29th October 2012 Medium/heavy vans, trucks and trailers built in one stage or first stage of a multi-stage build.
29th April 2013 Light vans and trucks built in multiple stages.
29th October 2013 Trailers built in multiple stages.
29th October 2014 Medium and heavy trucks built in multiple stages and other special purpose vehicles, such as mobile cranes and trailer caravans.

A successful inspection will result in the issuance of ECWVTA certificate. This certificate will be accepted throughout the European Union without the need for further testing until standard is updated or a new certificate is required due to design changes.

Once a vehicle is approved, the manufacturer should have processes in place to produce a Certificate of Conformity (CoC) for each vehicle manufactured. (1999/37/EC CoC document valid for 27 European Community Member States).

Conformity of Production (CoP) is part of the approval process. Essentially, this involves the evaluation of the manufacturing process to ensure that each product is manufactured in accordance with the approval specification.

Reference is made to a formal quality system in place, such as ISO 9001 or ISO/TS 16949. Many areas of a vehicle are not covered by the approval and as such will not have impact on the type, so it is possible to include box vans, curtain-siders, tippers and flatbeds on the same approval and it may not matter if other equipments (such as cranes, etc.) were fitted.

Certification - Main steps of the Type Approval process are:
  • Application by the vehicle or component manufacturer;
  • Testing by a technical service;
  • Granting of the approval by an Approval Authority;
  • Conformity of Production by the manufacturer in agreement with the Approval Authority;
  • Certificate of Conformity by the manufacturer for the end-user.

For further details on the new 2007/46/EC Directive, please consult Structure of Directive, Scope of Directive, Legislation page or Obelis’ services page.

Contact us for additional information or Get a Quote!

MVD 2007/46/EC | Structure | Scope | Compliance | MVD 2007/46/EC Services The requirement for EC type-approval for access to the internal market used to apply to private cars, motorcycles, mopeds and agricultural tractors. The European Union is extending this system to all categories of motor vehicles designed and constructed in one or more stages for use on the road and also to the systems, components and separate technical units designed and constructed for such vehicles. More precisely, the Directive 2007/46/EC is aimed at commercial vehicles (vans, lorries, semi-trailers, trailers), buses and coaches.

For further details on the new 2007/46/EC Directive, please consult Structure of Directive, Compliance with the Directive, Legislation page or Obelis’ services page.

Contact us for additional information or Get a Quote!

MVD 2007/46/EC | Structure | Scope | Compliance | MVD 2007/46/EC Services The Directive 2007/46/EC is structured in 51 Articles by 17 chapters and 21 Annexes. Below is a breakdown of the Chapters, Articles and Annexes:

CHAPTER I – General Provisions
CHAPTER II - General Obligations
CHAPTER III – EC-Type Approval Procedures
CHAPTER IV – Conduct of EC-Type Approval Procedures
CHAPTER V – Amendments to EC-Type Approval
CHAPTER VI – Validity of an EC-Type Approval of vehicles
CHAPTER VII - Certificate of Conformity and Markings
CHAPTER VIII – New Technologies or concepts incompatible with separate Directives
CHAPTER IX – Vehicles produced in small series
CHAPTER X – Individual Approvals
CHAPTER XI – Registration, Sale and Entry into Service
CHAPTER XII - SAFEGUARD Clauses
CHAPTER XIII - International Regulations
CHAPTER XIV – Provision of Technical Information
CHAPTER XV – Implementation of Measures and Amendments
CHAPTER XVI – Designation and Notification of Technical Services
CHAPTER XVII – Final Provisions


Article 1: Subject Matter
Article 2: Scope
Article 3: Definitions
Article 4: Obligations of Member States
Article 5: Obligations of Manufacturers
Article 6: Procedures for the EC type-approval of vehicles
Article 7: Procedures for the EC type-approval of systems, components or separate technical units
Article 8: General Provisions
Article 9: Specific Provisions concerning vehicles
Article 10: Specific provisions concerning systems, components or separate technical units
Article 11: Tests required for EC type-approval
Article 12: Conformity of production arrangements
Article 13: General provisions
Article 14: Specific provisions concerning vehicles
Article 15: Specific provisions concerning systems, components or separate technical units
Article 16: Issue and notification of amendments
Article 17: Termination of validity
Article 18: Certificate of conformity
Article 19: EC type-approval mark
Article 20: Exemptions for new technologies or new concepts
Article 21: Action required
Article 22: EC type-approval of small series
Article 23: National type-approval of small series
Article 24: Individual approvals
Article 25: Specific provisions
Article 26 Registration, sale and entry into service of vehicles
Article 27 Registration, sale and entry into service of end-of-series vehicles
Article 28 Sale and entry into service of components and separate technical units
Article 29: Vehicles, systems, components or separate technical units in compliance with this Directive
Article 30: Vehicles, systems, components or separate technical units not in conformity with the approved type
Article 31: Sale and entry into service of parts or equipment which are capable of posing a significant risk to the correct functioning of essential systems
Article 32: Recall of vehicles
Article 33: Notification of decisions and remedies available
Article 34: UNECE Regulations required for EC type-approval
Article 35: Equivalence of UNECE Regulations with directives or regulations
Article 36: Equivalence with other regulations
Article 37: Information intended for users
Article 38: Information intended for manufacturers of components or separate technical units
Article 39: Implementation measures and amendments to this Directive and the separate directives and regulations
Article 40: Committee
Article 41: Designation of technical services
Article 42: Assessment of the skills of the technical services
Article 43: Procedures for notification
Article 44: Transitional provisions
Article 45: Application dates for EC type-approval
Article 46: Penalties
Article 47: Assessment
Article 48: Transposition
Article 49: Repeal
Article 50: Entry into force
Article 51: Addressees


Annex I Complete list of information for the purpose of EC type-approval of vehicles
Annex II Definition of vehicle categories and vehicle types
Annex III Information document for the purpose of EC type-approval of vehicles
Annex IV List of requirements for the purpose of EC type-approval of vehicles
  • Appendix: List of requirements for EC type-approval of vehicles belonging to category M1, produced in small series
Annex V Procedures to be followed during EC type-approval of vehicles
  • Appendix 1: Standards with which the entities referred to in Article 41 have to comply
  • Appendix 2: Procedure for the assessment of the technical services
Annex VI EC type-approval certificate
  • Appendix: List of the regulatory acts to which the type of vehicle complies
Annex VII EC type-approval certificate numbering system
  • Appendix: EC component and separate technical unit type-approval mark
Annex VIII Test results
Annex IX EC Certificate of conformity
Annex X Conformity of production procedures
Annex XI Nature of and provisions for special purpose vehicles
  • Appendix 1: Motor-caravans, ambulances and hearses
  • Appendix 2: Armoured vehicles
  • Appendix 3: Wheel-chair accessible vehicles
  • Appendix 4: Other special purpose vehicles (including trailer caravans)
  • Appendix 5: Mobile cranes
Annex XII Small series and end-of-series limits
Annex XIII List of parts or equipment which are capable of posing a significant risk to the correct functioning of systems that are essential for the safety of the vehicle or its environmental performance, their performance requirements, appropriate test procedures, marking and packaging provisions
Annex XIV List of EC type-approvals issued pursuant to regulatory acts
Annex XV List of the regulatory acts for which a manufacturer may be designated as technical service
Annex XVI List of the regulatory acts for which virtual testing methods may be used by a manufacturer or a technical service
  • Appendix 1: General conditions required from virtual testing methods
  • Appendix 2: Specific conditions concerning virtual testing methods
Annex XVII Procedures to be followed during multi-stage EC type-approval
  • Appendix: Model of the manufacturer’s additional plate
Annex XVIII Certificate of origin of the vehicle — Manufacturer’s declaration of base/incomplete vehicle which is not provided with a Certificate of Conformity
Annex XIX Timetable for the enforcement of this Directive in respect of type-approval
Annex XX Time-limits for the transposition of repealed directives into national law
Annex XXI Correlation table

For further details on the new 2007/46/EC Directive, please consult Scope of Directive, Compliance with the Directive, Legislation page or Obelis’ services page.

Contact us for additional information or Get a Quote!

MVD 2007/46/EC | Structure | Scope | Compliance | MVD 2007/46/EC Services

The Medical Devices Directive referrers to two specific manners of placing medical devices together under a single packaging onto the European Market:

- "Systems"or "Procedure Packs" (MDD 93/42/EEC Article 12);

A "procedure pack" can be defined as an assembly of medical devices that are packed together and sold on the market with the intention of being used during procedures (e.g., surgical procedure) or medical treatment.

The devices in the "procedure pack" are not required to be used in combination or at the same time. Moreover, the manufacturer of the procedure pack may be the manufacturer of all the devices from the procedure pack, or may put in the procedure pack devices having different manufacturers.

Example of procedure packs:
  • First aid kits;
  • Packs for specific surgical procedure;
  • Orthodontic procedure packs.

A "system" can be defined as an assembly of medical devices that are designed to be used solely in combination one with the other, and cannot achieve the claimed medical intended purpose alone (see scope of a medical device).

Example of systems:
  • Prosthetic system;
  • Joint replacement system.

Please note that a "system" or "procedure pack" (KITs) comprising medical devices, all devices must undergo individual conformity assessment procedures and bear the CE marking individually while the KIT itself will not be CE marked;

Steps to place a KITS on the EU market

Step 1. Compliance with all the essential safety & health requirements that apply to the device (see compliance with the MDD 93/42/EEC); Step 2. Non-EU Manufacturer appointing an Authorized Representative in Europe;
Step 3. Notification the Competent Authority of the intention of placing a Medical Kit ("System" or "Procedure Pack" onto the European Market ( MDD 93/42/EEC Article 12));

MDD 93/42/EEC | Structure | Scope | Compliance | Custom made devices | Kits | Amendment 2007/47/EC | Clinical Investigation of the MDD 93/42/EEC | MDD 93/42/EEC Services The Medical Devices Directive and the Active Implantable Medical Devices Directive define the "custom-made device" as any device which is specifically made in accordance with a duly qualified medical practitioner's written prescription which gives, under his responsibility, specific design characteristics. A custom-made device is intended for the sole use of a particular patient. (MDD 93/42/ EEC Article 1 (2) (c); AIMDD 90/385/EEC Article 1 (2) (d)).

  • Examples of qualified medical practitioners: Dentist, Ophthalmologist, Orthotist, Ocularist.
  • Example of custom-made devices: Orthopaedic footwear, Maxillofacial Prosthesis.

Special note: mass-produced devices which need to be adapted to meet the requirements of a healthcare professional, even though they are supplied for the sole use of a particular patient, are not considered as custom-made. (e.g., contact lenses).

Steps to place a custom-made device on the EU market

Step 1. Compliance with all the essential safety & health requirements that apply to the device (see compliance with the MDD 93/42/EEC or compliance with the AIMDD 90/385/EEC);
  • Comply with the essential requirements (MDD 93/42/EEC Annex I, AIMDD 90/385/EEC Annex 1);
  • Technical documentation (MDD 93/42/EEC Annex VIII Point 3.1; AIMDD90/385/EEC Annex Point 6) ;
  • Vigilance system;
  • Step 2. Non-EU Manufacturer appointing an Authorized Representative in Europe;
    Step 3. Draw up a statement concerning the custom-made device (MDD 93/42/EEC Annex VIII Point 2.1; AIMDD 90/385/EEC Annex 6 Point 2.1);
    Step 4. Notification the Competent Authority of the intention of placing a Custom Made device onto the European Market ( MDD 93/42/EEC Article 11 (6));

    Custom-made devices do not bear the CE marking. (MDD 93/42/EEC Article 17 (1); AIMDD 90/385/EEC Article 12 (1)) ;

    Custom-made devices do not require the intervention of a Notified Body.

    Non-Compliance

    The directive portrays European Law enforced within the European Economic Area (EEA); non-compliance with the directive’s requirements will result in the removal of the device from the EEA. (MDD 93/42/EEC Annex VIII (5));

    MDD 93/42/EEC | Structure | Scope | Compliance | Custom made devices | Kits | Amendment 2007/47/EC | Clinical Investigation of the MDD 93/42/EEC | MDD 93/42/EEC Services Regulatory Changes

    The new regulation implies greater risk for the “responsible person” (Authorized Representative) in terms of product safety. It gives clear requirements for generating, keeping and updating information. Hence, the major responsibility in regard to the safety of a cosmetic product will rely on the “responsible person” (Authorized Representative).


    The “responsible person” will carry out the legal obligations of the cosmetic manufacturer or importer in regard to the new regulation, including but not limited to registration, maintenance of product files, safety assessments, etc.


    Furthermore, in regard to product safety, the Regulation underlines strict requirements for the content of the Safety Assessment and that of the Product Information File (Annex I), as well as the responsibilities of the “responsible person” (Authorized Representative) and the Safety Assessor.


    The process of registration is changed by the notification of sales and compositional information being delivered to the Commission, who will circulate the information to Poison Centres and Member States.


    The new regulation introduces changes in regard to the notification, evaluation and labeling requirements for all cosmetic products that contain nanomaterials. Furthermore, additional safety assessment provisions related to nanomaterials have also been incorporated in the regulation.


    Moreover, the regulation will allow the use of Carcinogenic, Mutagenic or Reprotoxic Substances if they have been evaluated and found safe by the SCCS (Scientific Committee for Consumer Products) for use in cosmetic products.


    Last, in line with the REACH Regulation, the new legislation stresses the need to make information available to the public and to the consumers.


    Market Surveillance

    There will be a section provided by the regulation (Chapter VII and Chapter VIII) in regard to Market Surveillance, Communication of Effects and Action to be taken if problems occur in the marketplace or if there are situations of non-compliance with the regulation.

    HOW TO GET YOUR DEVICES REGISTERED IN ITALY?

    Documentation needed:

    In order to proceed with the device registration Obelis will need from you the following information in an electronic format:

    - 1 manufacturer’s representative designation document signed (template to be provided)
    - 1 list of the Medical device (those which are / will be sold in Italy)
    - 1 technical file for each product (.pdf or .doc)
    - 1 copy of valid CE certificate
    - 1 copy of valid ISO certificate
    - 1 GMDN codes of the products to be registered *.
    Registration number will be provided at the end of the process.


    * The device registration in Italy has to be made also per GMDN code.  If you are not familiar with GMDN, the Global Medical Device Nomenclature (GMDN) provides the use of generic descriptors for the identification of medical devices and other Healthcare related products.

    If you do NOT know the GMDN codes for your products, Obelis can find them out for you, this is a separate service we provide to our clients.  We would need from you a very accurate product description (usage, composition).


    Process & Time frame (6-8 weeks) dependent on:

    1.    All the documents have been provided to Obelis’ Notification department.
    2.    The number of products in question (time might be longer in case of a large   quantity of products).
    3.    The Italian Competent Authority promptitude.
    4.    The Italian Database functionality.


    For further inquiry and to begin the Italian Device Registration Process please contact Obelis C.O.O. Mr. Doram Elkayam at

    The CE Marking Directive 93/68/EEC was adopted on July 22, 1993 and its purpose being to introduce a harmonized set of rules relating to the affixing and use of CE marking.

    The letters “CE” are the abbreviation of French phrase “Conformité Européene” which literally means “European Conformity”.

    CE Marking on a product is a manufacturer’s declaration that the product complies with the essential requirements of the relevant European health, safety and environmental protection legislations in practice by many of the so-called product directives.

    It proves to the buyer or user that this product fulfills all essential safety and environmental requirements as they are defined in the so-called European Directives.

    The CE Marking Directive gives a detailed description of the initials CE and any other marks specific to a particular directive and the ways conformity may be acquired.

    Products meeting the requirements of all appropriate directives must carry the CE mark. It may not be smaller than 5mm in its vertical height and the proportions should be maintained whatever its size. The grid does not form part of the marking. It is for information only. It should be noted that the C and the E are not formed by perfect semicircles.

    The manufacturer needs to:
    • Be European
    • Have an official department in the European Community
    • Have an official agent or representative that is willing to share the liability for the CE marking and hold the Declaration of Conformity.

    CE Marking 93/68/EEC | Directive | Structure | Scope | Compliance

    Demonstrating compliance with the AIMDD requires CE certification by a Notified Body, which involves some of the following:

    1. Essential Requirements
      • General requirements (” The devices must be designed and manufactured in such a way, that their use does not compromise the clinical condition or the safety of patients.”)
      • Requirements regarding design and construction
    2. EC Declaration of Conformity (Complete quality assurance system)

      • Quality system
      • Examination of the design of the product
      • Surveillance
      • Administrative provisions(the declaration of conformity)
    3. EC Type- Examination

      • Make an application for evaluation of quality system to a notified body (Annex III, section 3)
    4. EC verification
    5.  

    6. EC Declaration of Conformity to Type

      • Quality system
      • Surveillance
    7. Statement concerning devices intended for special purposes
    8.  

    9. Clinical evaluation

      • Clinical investigation (purpose, ethical consideration, methods)
    10. Minimum criteria to be met when designating inspection bodies to be notified
    11.  

    12. CE conformity marking



    AIMDD 90/385/EEC | Structure | Scope | Compliance | AIMDD 90/385/EEC Services

    Medical devices (as a whole) include any instrument, appliance, software, etc. used for the purpose of prevention (e.g. vaccine-delivery devices), screening (e.g. mammography for breast cancer), diagnosis (e.g. use ultrasound system) treatment, or alleviation of disease. Medical devices are currently regulated under three main Directives covering:
    1. Active Implantable Medical Devices (AIMD),
      2. Medical Devices (MDD)
      3. In Vitro Diagnostic Medical Devices (IVDD)
    AIMD is classified as a device which must rely on a source not provided by the body or gravity and be designed to be introduced into the body with the intention to remain there following the procedure. The directive specifies that these products should meet essential safety requirements in terms of function, sterility, material compatibility, marking, user instructions and design documentation. In addition there are requirements for type approval, production quality management, clinical investigation and manufacturer registration.

    AIMDD 90/385/EEC | Structure | Scope | Compliance | AIMDD 90/385/EEC Services

    The AIMDD 90/385/EEC amended by the 2007/47/EC consists of 17 Articles and 9 Annexes. These Articles define the attributes of a medical device which is characterized according to the directive as well as the harmonized standards that these devices must meet. The Annexes list the general requirements for EC Verification.
    Annex1- ESSENTIAL REQUIREMENTS
    Annex 2- EC DECLARATION OF CONFORMITY
    Annex 3- EC Type-EXAMINATION
    Annex 4- EC VERIFICATION
    Annex 5- EC DECLARATION OF CONFORMITY TO TYPE
    Annex 6- STATEMENT CONCERNING DEVICES INTENDED FOR SPECIAL PURPOSES
    Annex 7- CLINICAL EVALUATION
    Annex 8- MINIMUM CRITERIA TO BE MET WHEN DESIGNATING INSPECTION BODIES TO BE NOTIFIED
    Annex 9- CE CONFORMITY MARKING

    AIMDD 90/385/EEC | Structure | Scope | Compliance | AIMDD 90/385/EEC Services

    The Manufacturer or Supplier should demonstrate that the product complies with the essential requirements, using one of the product conformity assessment modules available within the directive. One of the options is usually the assessment of the product by applying the relevant standards to the product, and/or the preparation of appropriate documentation such as the Technical File. The CE Mark should be affixed legibly and indelibly to the product. The manufacturer should prepare and sign a “Declaration of Conformity”.

    Many of the CE Marking directives include provision for the appointment of Notified Bodies. These are organizations appointed by Member States in which they are based and whose details are “Notified” to the European Commission. The Commission must then publish these details in the Official Journal of the European Communities.
    Notified Bodies perform specific functions, as defined by the directives, in relation to the assessment of compliance of specific products. For many of the directives their involvement is only mandatory for higher risk and safety critical products.

    CE Marking 93/68/EEC | Directive | Structure | Scope | Compliance

    The CE Marking of products is intended to support the free movement of goods within the European Economic Area. All products that bear CE marking must comply with all provisions of the applicable directives. Where a product carries appropriate CE marking, the member countries of the European Economic Area must allow the product to be placed on the market.

    CE Marking directives cover many product areas. The current CE marking directives are:
    • Low Voltage Directive 73/23/EEC (amended 93/68/EEC)
    • Simple Pressure Vessels 87/404/EEC (amended 90/488/EEC, 93/68/EEC)
    • Toy Safety 88/378/EEC (amended 93/68/EEC)
    • Construction Products 89/106/EEC (amended 93/68/EEC)
    • Electromagnetic Compatibility 89/336/EEC (amended 92/31/EEC, 93/68/EEC, 98/13/EC)
    • Machinery 98/37/EC (amended 98/79/EC)
    • Personal Protective Equipment 89/686/EEC (amended 93/68/EEC, 93/95/EEC, 96/58/EC)
    • Non-Automatic Weighing Instruments 90/384/EEC (amended 93/68/EEC)
    • Active Implantable Medical Devices 90/385/EEC (amended 93/68/EEC, 93/42/EEC, 98/79/EC)
    • Gas Appliances 90/396/EEC (amended 93/68/EEC)
    • Hot Water Boilers 92/42/EEC (amended 93/68/EEC)
    • Civil Explosives 93/15/EEC
    • Medical Devices 93/42/EEC (amended 93/68/EEC, 98/79/EC)
    • Potentially Explosive Atmospheres 94/9/EC
    • Recreational Craft 94/25/EC
    • Lifts 95/16/EC
    • Refrigeration Appliances 96/57/EC
    • Pressure Equipment 97/23/EC
    • Telecommunications Terminal Equipment 98/13/EC
    • In-Vitro Diagnostics 98/79/EC
    • Radio and Telecommunications Terminal Equipment 99/5/EC

    New Approach Directives that do not require CE Marking are:
    • Packaging and Packaging Waste 94/62/EC
    • High Speed Rail Systems 96/48/EC
    • Marine Equipment 96/98/EC

    The Marking should be affixed to one of the following:
    • the product itself
    • the packaging of the product
    • the instructions for use
    • the guarantee certificate

    By affixing the CE marking to the product a manufacturer is making a statement that product meets the requirement of all relevant directives. It is for the manufacturer to decide which directives are applicable.

    CE Marking 93/68/EEC | Directive | Structure | Scope | Compliance

    The CE Marking Directive 93/68/EEC of July 22, 1993 has 15 articles.

    The directive contains all the information necessary to enable a manufacturer to apply the directive, and comply with it. The directive includes test methods, where these are necessary, test limits, and certification requirements. However, when considering the more complex areas of product assessment, it proved impossible to write directives that contained this information.


    CE Marking 93/68/EEC | Directive | Structure | Scope | Compliance

    1. The notification of “IVD” product families as per IVDD 98/79/EC (Article 10) can only be completed through the appointed “European Authorized Representative”
    2. Establishment of relations with Obelis – meaning you as a Non-EU manufacturer appointing Obelis as your European Authorized Representative as required by the directive- doing so by mutually signing an E.A.R agreement which will be presented to you upon your request
    3. Obelis will need to receive from you all the required documentations in their Original format, something which will be explained to you by our notification department once you will become a client (the documentation which is required is mainly filled out templates which we will present you with) allowing us to compile the Notification file to be submitted first to the European IVD Authorities where the European Authorized Representative is established (in this instance Belgium)
    4. Obelis will submit the Notification file in your behalf acting as your appointed European Authorized Representative as required by the European Directive
    5. Within two weeks time Obelis will be able to equip you with the “Certification of CE Registration” which will be your proof that your file has been duly submitted to the European Authorities.
    6. Upon submission of the Notification File- the Authorities will require the remittance of a Notification Tax
    7. Obelis will then submit your file to the required EU Member State competent authorities (dependant on your instructions prior to market entry) and equip you with a “Certification of CE Registration” for each of the requested countries (within two weeks time of submission) - when this document is received by you- you may commence Sales!

     

    1. The notification of “IVD” product families as per IVDD 98/79/EC (Article 10) can only be completed through the appointed “European Authorized Representative”
    2. Establishment of relations with Obelis – meaning you as a Non-EU manufacturer appointing Obelis as your European Authorized Representative as required by the directive- doing so by mutually signing an E.A.R agreement which will be presented to you upon your request
    3. Obelis will need to receive from you all the required documentations in their Original format, something which will be explained to you by our notification department once you will become a client (the documentation which is required is mainly filled out templates which we will present you with) allowing us to compile the Notification file to be submitted first to the European IVD Authorities where the European Authorized Representative is established (in this instance Belgium)
    4. Obelis will submit the Notification file in your behalf acting as your appointed European Authorized Representative as required by the European Directive
    5. Within two weeks time Obelis will be able to equip you with the “Certification of CE Registration” which will be your proof that your file has been duly submitted to the European Authorities.
    6. Upon submission of the Notification File, the Authorities will require the remittance of a Notification Tax
    7. Obelis will then submit your file to the required EU Member State competent authorities (dependant on your instructions prior to market entry) and equip you with a “Certification of CE Registration” for each of the requested countries (within two weeks time of submission) - when this document is received by you, you may commence Sales!

     

    Objective of clinical investigation:

    • To verify that, under normal conditions, the performance of the devices conform with the Medical Device Directive
    • To determine any undesirable side-effects, under normal condition of use, and assess whether they constitute risks when weighed against the intended performance of the device.

    Notification procedure according to MDD 93/42/EEC, articles 15. 1, 2 & 3 and Annex VIII, 2.2, 3.2 and 4

    • A manufacturer or his Authorized Representative has to notify the competent authorities of the Member States in which the investigation is to be conducted (MDD 93/42/EEC, article 15, 1)
    • The manufacturer or his appointed authorized representative must draw a statement before conducting a clinical investigation (MDD 93/42/EEC, Annex VIII, 2.2)
    • The clinical trial can only start at the end of 60 days after notification in case of Class III and implantable and long-term invasive devices falling within Class IIa or IIb. However, the competent authority may authorize manufacturer to commence the clinical investigation before the end of the 60 days in case the relevant ethics committee has issued a favourable opinion on the programme of the investigation. (MDD 93/42/EEC, article 15, 1 & 2)
    • The clinical trial may start after the date of notification if the competent authority authorizes the manufacturer to do so provided that the ethics committee has delivered a favourable opinion relating to the investigation.(MDD 93/42/EEC, article 15, 3)
    • The investigation must be performed under the responsibility of a medical practitioner or another authorized qualified person in an appropriate environment (MDD 93/42/EEC, article 15)
    • A report has to be written and signed by the medical practitioner or other authorized responsible person. The report must contain critical evaluation of all the data collected during the clinical investigation.(MDD 93/42/EEC, article 15)
    • The information should be kept available for a period of at least 5 years (MDD 93/42/EEC, Annex VIII, 4)

     

    • Our relations need to be established – meaning you as a Non-EU manufacturer appointing Obelis as your European Authorized Representative as required by the directive- doing so by mutually signing an E.A.R agreement which will be presented to you upon your request.
    • A fee will be required (against an invoice which will be issued) for your 1st Notification file which will hold ALL of your current Class I medical devices allowing Obelis to prepare and submit this file to the European Authorities.
    • We will need to receive from you all the required documentations in their original format, something which will be explained to you by our notification department once you will become a client (the documentation which is required is mainly filled out templates which we will present you with) allowing us to compile the registration file to be submitted to the European Authorities.
    • Obelis will then submit the registration file in your behalf acting as your appointed European Authorized Representative as required by the European Directive for Medical Devices.
    • Within two weeks time Obelis will be able to equip you with the “Certification of CE Registration” which will be your proof that your file has been duly submitted to the European Authorities. From this point you may affix the CE marking on your product and commence sales. Obelis will guide you through the correct manner of affixing the CE marking on your device (with the accompanying documentation which needs to be available) and the correct manner in which a product needs to be in order to enter the European community.
    • Within a period of time (dependent on the Authorities’ work load) we shall receive the registration codes on your registration file from the Authorities (there will be a Tax for the release of these codes- 124.00 Euros)- these codes (which will actually replace the Certification of CE Registration as a valid proof that you as a manufacturer and your devices are complying with the European Regulation applicable to your type of device) will need to be kept in your files but do not require to be mentioned on your devices or on your CE certificate (your EC Declaration of Conformity will act as your CE certificate as explained).

     

    The scope of the Pressure Equipment Directive is rather wide, covering equipment such as:

    • Reaction vessels
    • Pressurised storage containers
    • Heat exchangers
    • Steam generators
    • Shell and water tube boilers
    • Industrial pipe work
    • Safety devices and pressure accessories

    Such pressure equipment is widely used in the process industries (chemical, petrochemical, biochemical, food processing), high temperature process industry, refrigeration and energy generation. Furthermore, the directive covers equipment normally used in any general engineering process (such as gas cylinders and certain compressed air equipment).

    Typical examples of safety devices include:

    • Safety valves
    • Buckling rods
    • Controlled safety pressure relief systems
    • Pressure switches
    • Temperature switches and fluid level switches

    PED 97/23/EC | Structure | Scope | Compliance | PED 97/23/EC Services

    The directive has 21 Articles and 7 Annexes. The Articles cover general items such as scope and definitions, placing devices on the market and putting them into service, free movement of CE-marked goods in Europe, reference to harmonized standards, vigilance and incident reporting, conformity assessment procedures, appointment of an authorized representative, consequences of wrongly affixed CE marking, confidentiality, etc.

    Annex I - The obligations arising from the essential requirements
    Annex II – Conformity Assessment Tables
    Annex III - Conformity Assessment Procedures
    Annex IV – Minimum criteria to be met when designating the notified bodies referred to in article 12 and the recognized third-party organizations referred to in article 13
    Annex V – Criteria to be met when authorizing user inspectorates referred to in article 14
    Annex VI – Appearance of the CE marking
    Annex VII – Content requirements for Declaration of Conformity

    Pressure equipment classification is based on the hazard presented by its application. Hazard is determined by the stored energy and the nature of the contained fluid. A manufacturer is obliged to classify the pressure equipment into one of four conformity assessment categories: Categories I to IV.

    Assessment and conformity measures differ according to a category, starting from self-certification for the lowest hazard -category I, ending with the full quality management and notified body testing for category IV equipment.

    The harmonized standards specify the aspects of the design, production and testing of the equipment. The standards provide information about all aspects of equipment design and production, including dimensions, materials, welding and test methods.

    PED 97/23/EC | Structure | Scope | Compliance | PED 97/23/EC Services

    According to the directive, pressure equipment and assemblies above specified pressure and/or volume thresholds must:

    • be safe
    • meet essential safety requirements covering design, manufacture and testing
    • satisfy appropriate conformity assessment procedures
    • carry the CE mark and other information

    Additional to the performance requirements, manufacturers are obliged to provide explicit instructions with equipment they sell, complete a specified declaration of conformity, as well as maintain a technical file of information about how the equipment was designed and manufactured.

    To ensure that products put on the European market meet the requirements of the PED, it is essential to establish the PED classification.  Pressure equipment classification is based on the hazard presented by its application. Hazard is determined by the stored energy and the nature of the contained fluid. A manufacturer is obliged to classify the pressure equipment into one of four conformity assessment categories: Categories I to IV.

    Assessment and conformity measures differ according to a category, starting from self-certification for the lowest hazard -category I, ending with the full quality management and notified body testing for category IV equipment.

    Upon completion of the conformity assessment and if the equipment or assembly complies with the provision of the Pressure Equipment Directive, the manufacturer is required to affix the CE-marking to each item of pressure equipment or assembly and draw up a Declaration of Conformity.

    For non-EU manufacturers: Appoint a European Authorized Representative established within the European Community.

    Non-Compliance

    The directive portrays European Law in forced within the European Economic Area (EEA); non-compliance with the directive’s requirements will result in the removal of the product from the market and the revoking of the CE marking affixed on the equipment.

    PED 97/23/EC | Structure | Scope | Compliance | PED 97/23/EC Services

    In order to ensure that a radio and telecommunications apparatus complies with the R&TTE Directive, the following steps must be taken:

    • Classification of the apparatus - this includes making sure that the R&TTE Directive is applicable to the apparatus and identifies the relevant laws and requirements applicable to the apparatus
    • Create technical file and conduct a compliance test
    • Identification of EU harmonized standards applicable to the apparatus
    • Notify the product to Competent Authorities if required (see article 31 of the directive)
    • Preparation of an “EC Declaration of Conformity”
    • Appoint a European Authorized Representative – the R&TTE Directive requires an EU representative for non-European manufacturers of radio and telecommunications apparatuses who wish to sell within the European Economic Area. An E.A.R. is responsible for keeping the equipment information available for the relevant competent authority. It is also the primary contact for EU authorities.

    Requirements according to the directive are as follows:

    • Protection of the health and safety of the user, including meeting requirements in the LVD 2006/95/EC and EMC 2004/108/EC Directives
    • The effective use of the spectrum allocated to the device so as not to cause harmful interference
    • The European Commission may also require that the apparatus interworks with other apparatuses, does not harm the network, ensures that the personal data of the user is protected and avoids fraud, allows access to emergency services and can be operated by disabled users

    Notification
    The apparatus shall only need to be notified to the relevant body of the Member State if it uses frequencies that are not harmonized in the EU (see Article 31 of the Directive).

    Placing on the market

    The apparatus should only be placed in the European Economic Area if it complies with the essential requirements of the directive. Then, the Member States shall not restrict the placing onto the market or putting into service the apparatus.
    For non-EU manufacturers: Appoint a European Authorized Representative established within the European Community.


    Non- Compliance

    The directive portrays European Law enforced within the European Economic Area (EEA); non-compliance with the directive’s requirements will result in the removal of the apparatus from the market and the revoking of the CE marking affixed on the apparatus.

    R&TTE 1999/5/EC | Structure | Compliance | R&TTE 1995/5/EC Services

    The Radio and Telecommunications Terminal Equipment Directive is divided up into 22 Articles and 7 Annexes. The Articles outline a number of different issues related to the directive from harmonized standards to CE marking. The Annexes summarize what is not considered or covered by the directive to establish standards for a full-quality assurance system. These Articles and Annexes are specific to make sure all requirements and standards are specifically outlined, so that entrance into the European Economic Area is obtained.

    Annex I-Equipment that is not covered by the directive

    Annex II-Conformity assessment procedure that must be followed by manufacturers or his established representative within the European Community

    Annex III-Adds on supplementary requirements for Annex II in reference to the conformity assessment procedure

    Annex IV-Establishes supplementary details to Annex III and placing the apparatus on the EEA

    Annex V-Describes what a full-quality assurance is as well as the defining of a quality system

    Annex VI-Minimum requirements needed to comply with by Member States when designating a Notified Body

    Annex VII-Description of the CE marking and its exact form to be taken on apparatuses placed in the EEA

    R&TTE 1999/5/EC | Structure | Compliance | R&TTE 1995/5/EC Services

    Devices which fall under the directive include:

    Any device, apparatus, appliance or material used on human beings for the purpose of diagnosing, treating, preventing, monitoring, or alleviating a person’s condition as well as in conjunction with those who are injured or handicap. A medical device can also be defined in this directive as any of the previously listed in concurrence with conception. If any of these relate to your device, it is classified as a medical device.

    MDD 93/42/EEC | Structure | Scope | Compliance | Custom made devices | Kits | Amendment 2007/47/EC | Clinical Investigation of the MDD 93/42/EEC | MDD 93/42/EEC Services

    There are general requirements for all 3 classes, including technical documentation,
    a CE mark and a Declaration of Conformity.

    The manufacturer must create a technical file.

    The Technical File shall consist of:

    1. Overall and detailed plans of the PPE accompanied, if appropriate, by calculation notes and the results of prototype tests in so far as is necessary for the verification of compliance with the basic requirements (Annex II of the PPE Directive). Personal Protective Equipment Directive FAQs 4/4
    2. An exhaustive list of the basic safety requirements and of the harmonized standards or other technical specifications used to demonstrate compliance with the basic requirements.
    3. Declaration of Conformity

    Other technical documentation that should be included, although not strictly part of the ‘Technical File’ is:

    1. A copy of the User Information or Instructions for Use supplied with the equipment
    2. A description of the control and test facilities to be used in the manufacturer’s plant to check compliance of production PPE with the harmonized standards or other technical specification.

    If the equipment is to be manufactured in series, an EC type-examination is required. This EC type declaration shall not be required in the case of PPE models of simple design where the designer assumes the user can himself assess the level of protection provided against the minimal risks concerning the effects of which, when they are gradual, can be safely identified by the user in good time. This category shall cover exclusively PPE intended to protect the wearer against:

    • Mechanical action whose effects are superficial (gardening gloves, thimbles, etc.)
    • Cleaning materials of weak action and easily reversible effects (gloves affording protection against diluted detergent solutions, etc.)
    • Risks encountered in the handling of hot components which do not expose the user to a temperature exceeding 50 °C or to dangerous impacts (gloves, aprons for professional use, etc.)
    • Atmospheric agents of a neither exceptional nor extreme nature (headgear, seasonal clothing, footwear, etc.)
    • Minor impacts and vibrations which do not affect vital areas of the body and whose effects cannot cause irreversible lesions (light anti-scalping helmets, gloves, light footwear, etc.)
    • Sunlight (sunglasses)

    In the case of PPE of complex design intended to protect against mortal danger or against dangers that may seriously and irreversibly harm health, the PPE will be subject to either “EC” quality control system for the final product or system for ensuring EC quality of production by means of monitoring and to an EC Declaration of Conformity.

    For non-EU manufacturers: Appoint a European Authorized Representative established within the European Community.

    Non-Compliance

    The directive portrays European Law enforced within the European Economic Area (EEA); non-compliance with the directive’s requirements will result in the removal of the product from the market and the revoking of the CE marking affixed on the equipment.

    PPE 89/686/EEC | Structure | Scope | Compliance | GPSD 2001/95/EC Services

    The PPE Directive (Personal Protective Equipment Directive) covers any device or appliance designed to be worn or held by an individual for protection against one or more health and safety hazards.

    This includes:

    • Equipment for protection against falls from a height
    • Head protectors (helmets and other headgear for professional and private use, face protectors for ice hockey players)
    • Protective clothing, gloves (chemical attack, heat)
    • Protective clothing (high visibility, reflecting materials)
    • Reflectors
    • Protective eyewear used in the game of floor ball

    PPE Directive applies to:

    • A unit constituted by several devices or appliances which have been integrally combined by the manufacturer for the protection of an individual against one or more potentially simultaneous risks
    • A protective device or appliance combined, reparably or inseparably, with personal non-protective equipment worn or held by an individual for the execution of a specific activity
    • Interchangeable PPE components which are essential to its satisfactory functioning and used exclusively for such equipment

    However the PPED does not apply to:

    • PPE designed and manufactured specifically for use by the armed forces or in the maintenance of law and order (helmets, shields, etc.)
    • PPE for self-defense (aerosol canisters, personal deterrent weapons, etc.)
    • PPE designed and manufactured for private use against:
      • Adverse atmospheric conditions (headgear, seasonal clothing, footwear, umbrellas, etc.)
      • Damp and water (dish-washing gloves, etc.)
      • Heat (gloves etc.)
    • PPE intended for the protection or rescue of persons on vessels or aircraft, not worn all the time
    • Helmets and visors intended for users of two- or three wheeled motor vehicles

    PPE 89/686/EEC | Structure | Scope | Compliance | GPSD 2001/95/EC Services

    Items such as scope and definition of Personal Protective Equipment, recognition of national standards, reference to the necessity of harmonized standards, effective quality control, conformity assessment procedures, Authorized Representative requirements, and consequences of wrongly affixed CE marking are all addressed in the directive.

    It is defined as “any device to be worn or held by an individual for protection against one or more health and safety hazards”. The directive divides PPE into 3 categories:

    • class 1 - simple
    • class 3 – complex
    • class 2 - neither of these

    For classes 1 and 3 there are comprehensive lists of equipment covered; any equipment not included
    on either list are classed in the second category. There is also a comprehensive list of equipment excluded from the directive.

    Annex I-lists classes of PPE products not covered by 89/686/EEC
    Annex II -describes basic health and safety requirements of all Personal Protective Equipment. It also includes the information requirements that must be supplied by the manufacturer to the consumer.
    Annex II-describe necessary safety elements to more particular categories of PPE.
    Annex III-specifies the technical documentation requirements such as:

    • Overall and detailed plans of the PPE
    • Calculation notes
    • Prototype tests
    • Basic safety
    • Harmonized standards specific to the model
    • Control and test facility description
    • Quality assurance system
    • Copy of EC Declaration of Conformity

    Annex IV-details the standards and appearance for use of the CE mark including the requirement of the original year of affixation
    Annex V-lists the requirements to be met by notified bodies that perform testing of PPE products
    Annex VI-specifies the information required for the EC declaration of conformity

    PPE 89/686/EEC | Structure | Scope | Compliance | GPSD 2001/95/EC Services

    The GPSD applies in a complementary way to products covered by product safety rules specific to their sector. A list of the sector specific legislation can be found in the “Pink Book” made by the Directorate-General for Enterprise and Industry. From a consumer point of view, the most important pieces of legislation are for cosmetics, toys, chemicals, personal protective equipment, pharmaceuticals, machinery and recreational craft. For any product that is not covered by a specific piece of legislation, the GPSD will apply by default.

    GPSD 2001/95/EC | Structure | Scope | Compliance | GPSD 2001/95/EC Services

    The manufacturer shall determine the applicable standards for the product, at national, European or the international level, and then identify the appropriate conformity assessment module according to the product classification. Finally, a full “Quality System” shall be implemented, which includes post-market surveillance, vigilance and traceability, a risk analysis report and a safety assessment report.
    Technical File Data & Declarations:

    1. “Risk Analysis report”
    2. “Safety Assessment”: You need to identify what kind of test your product was submitted to and test report(s).
    3. Complete (exhaustive) list of standards your product is currently complying with. (US, EN, ISO, others…)
    4. US standards certificates, ISO certificates, if any.
    5. A Declaration of Conformity that you have appointed a “European Authorized Representative”.
    6. Copy of your “Quality Manual”
    7. Copy of your product package insert/instructions of use: (a) please note that according to the European Directive 2001/95/EC, you should specify, very clearly, which are the possible risks your product could expose the end user to. A Warning/Caution should be clearly stated in your product package insert. Moreover, the Competent Authorities insisted that your product package insert should clearly mention the exact and safe intended use of your product and possible side effects, if any.

      (b) Language requirements: The Royal Decree (Implementation of the directive in the Belgian law) on “General Product Safety” article 8, requires the manufacturer to release the product if it is an end user’s product, with all relevant labeling and package insert at least in one of the national languages (Belgium: French, Dutch or German). As language requirements are left to each EU Member State specific regulation, you should keep available labeling and package inserts in each EU Member state official language(s). Of course, we will be able to help you identifying all EU Member States specific language requirements.
    8. Labeling: (a) This labeling should clearly mention both manufacturer’s name and complete details (address, tel., fax, email address) and the “European Authorized Representative” complete details (address, tel., fax, email address)

      (b) Language requirements: see above product package insert.
    9. Post Market Surveillance: Complete file (procedures, forms, etc.)
    10. Vigilance & Traceability: description. (Read carefully 2001/95/EC European Council Directive, chapter III, article 5)

    For non-EU manufacturers: Appoint a European Authorized Representative established within the European Community.


    Non-Compliance

    The directive portrays European Law enforced within the European Economic Area (EEA); non-compliance with the directive’s requirements will result in the removal of the product from the market.

    GPSD 2001/95/EC | Structure | Scope | Compliance | GPSD 2001/95/EC Services

     

    The General Product Safety Directive consists of 24 Articles and 4 Annexes. These Articles and Annexes are in place to make sure all products placed in the European Economic Area are safe. The scopes of the Articles include conformity assessment criteria as well as obligations of distributors. The Annexes also inform by explaining what products do not apply to the directive and guidelines for notification.

    Annex I-Requirements concerning information on products that do not comply with the directive must be provided to the competent authorities by producers and distributors
    Annex II-Procedure for the application of Rapex which is in reference to products that have severe safety and health risks
    Annex III-Period for transposition and application of the repealed directive
    Annex IV-Correlation table which references Articles that are related to one another

    GPSD 2001/95/EC | Structure | Scope | Compliance | GPSD 2001/95/EC Services

    The directive covers electrical equipment designed for use with a voltage rating between 50 and 1000 V for an alternating current and between 75 and 1500 V for a direct current. These voltage ratings refer to the voltage of the electrical input or output, not to voltages that may appear inside the equipment. For most electrical equipment, the health aspects of emissions of electromagnetic fields are also under the domain of the Low Voltage Directive.

    However, the following are excluded from the scope of the “Low Voltage” Directive:

    • Electrical equipment for use in a potentially explosive atmosphere
    • Electrical equipment for radiology and medical purposes
    • Electrical parts for lifts
    • Electricity meters, which are covered by other Community directives
    • Plugs and socket outlets for domestic use
    • Electric fence controllers
    • Radio-electrical interference
    • Specialized electrical equipment, for use on ships, aircraft or railways which complies with the safety provisions drawn up by international bodies in which the Member States participate, which so far are not covered by any Community directive and therefore must not be CE marked

    LVD 2006/95/EC | Structure | Scope | Compliance | LVD 2006/95/EC Services

    The Low Voltage Directive (LVD) 2006/95/EC has 16 Articles and 6 Annexes. Being one of the oldest European directives, was originally published in 1973 and has two modifications, 93/68/EEC, published on July 22, 1993 and 2006/95/EC published on December 27, 2006.

    The Articles cover general items such as: definitions, basic safety requirements, quality practices, market obstruction, international notification procedures, harmonized standards, and national standards.

    Annex I- Principal elements of the safety objectives for electrical equipment designed for use within certain voltage limits
    Annex II - List of equipment and phenomena outside its scope, because they are covered by other directives
    Annex II - CE Conformity Marking and EC Declaration of Conformity
    Annex IV - Internal Production Control
    Annex V - Repealed directive with its amendment and list of time-limits for transposition into national law and application
    Annex VI - Correction table – Directive 73/23/EEC

    LVD 2006/95/EC | Structure | Scope | Compliance | LVD 2006/95/EC Services

    Article 8 and Annex IV of the directive describe the procedure by which the manufacturer
    or his authorized representative established in the Community ensures and declares conformity
    of the electrical equipment with the provisions of the directive. This includes three main elements:

    • Technical documentation-Before electrical equipment is placed in the European Economic Area the manufacturer puts together the technical documentation which makes it possible to assess whether the electrical equipment complies with the requirements of the directive.
    • Declaration of Conformity-The manufacturer or his authorized representative established in the Community is also required, and are the only ones authorized to do so, to draw up in writing a Declaration of Conformity before placing the electrical equipment on the market.
    • CE marking-Before it is placed in the EEA, the electrical equipment must have the CE marking affixed. Only the manufacturer or his authorized representative established in the Community are authorized to affix the CE marking.

    Technical documentation

    This must include details of the design, manufacture and operation of the electrical equipment in so far
    as these details are needed to assess the conformity of the electrical equipment with the requirements of the directive.

    Accordingly, it contains:

    • A general description of the electrical equipment
    • Design and manufacture drawings plus diagrams of components, subassemblies, circuits, etc.
    • Descriptions and explanations needed to understand the above mentioned drawings and diagrams plus the operation of the electrical equipment
    • A list of the standards used, in full or in part, and a description of the solutions employed to meet the safety aspects of this directive when standards have not been applied
    • The results of design calculations and of checks carried out, etc.
    • Test reports (in fact, the test reports which may be available, either established by the manufacturer or a third party)

    CE marking

    The CE marking is placed by the manufacturer, or his Authorized Representative established
    in the Community, on the electrical equipment or, where this is not practically possible, on the packaging, the instructions for use or the guarantee. The CE marking declares conformity of electrical equipment with the essential requirements and conformity assessment procedures set out under the “Low Voltage” Directive and all the other directives applicable to it.

    The CE marking must be affixed visibly, legibly and indelibly. The affixing of markings which are likely to deceive third parties as to the meaning and form of the CE marking is prohibited.

    Declaration of conformity:

    Annex III.B of the directive describes the content of the Declaration of Conformity as follows:

    • Name and address of the manufacturer or his authorized representative established within the Community
    • A description of the electrical equipment
    • Reference to the harmonized standards
    • Where appropriate, reference to the specifications on which conformity is declared
    • Identification of the signatory who has been empowered to enter into commitments on behalf of the manufacturer or his authorized representative established within the Community
    • The last two digits of the year in which the CE marking was affixed (for the first time)

    The Declaration of Conformity must be drawn up at least in one of the official languages of the Community.

    For non-EU manufacturers: Appoint a European Authorized Representative established within the European Community.

    Non-Compliance

    The directive portrays European Law enforced within the European Economic Area (EEA); non-compliance with the directive’s requirements will result in the removal of the apparatus from the market and the revoking of the CE marking affixed on the electrical equipment.

    LVD 2006/95/EC | Structure | Scope | Compliance | LVD 2006/95/EC Services

    The EMC Directive 2004/108/EC applies to a vast range of equipment encompassing electrical
    and electronic appliances, systems and installations.

    The Directive 2004/108/EC applies to:

    • Electrical and electronic appliances, systems, and installations including electrical and electronic appliances
    • Fixed installations
    • Devices and subassemblies intended to be included in an apparatus by the final user and mobile installations

    It excludes:

    • Equipment covered by the radio and telecommunications terminal
    • Equipment Directive 1999/5/EC
    • Radio equipment used by radio amateurs
    • Equipment where EMC is covered by other specific directives, such as marine equipment
    if covered by Directive 96/98/EC or active implantable medical devices under the 90/385/EEC Directive
    • Inherently benign equipment

    This directive shall not apply to:

    • Equipment when covered under the radio equipment and telecommunication terminal directive R&TTE, nor aeronautical products, parts and apparatus, nor radio equipment used by amateur radio operators
    • Equipment incapable of generating or contributing to electromagnetic emissions
    and/or operates without unacceptable degradation in the presence of electromagnetic disturbance as normally seen in its intended use


    EMC 2004/108/EC | Structure | Scope | Compliance | EMC 2004/108/EC Services

    The Electromagnetic Compatibility 2004/108/EC Directive has 16 Articles and 6 Annexes. The Articles cover general items such as scope and definitions, placing electrical equipment on the market and putting them into service, free movement of CE marked goods in EU Member States, reference to harmonized standards, vigilance and incident reporting, conformity assessment procedures, registration responsibilities, Authorized Representative compliance, consequences of wrongly affixed CE marking and confidentiality.

    Annex 1- Essential requirements referred to in Article 5
    Annex 2 - Conformity assessment procedure referred to in Article 7
    Annex 3 - Conformity assessment procedure referred to in Article 7
    Annex 4 - Technical documentation and EC Declaration of Conformity
    Annex 5 - CE marking referred to in Article 8
    Annex 6 - Criteria for the assessment of the bodies to be notified

    EMC 2004/108/EC | Structure | Scope | Compliance | EMC 2004/108/EC Services

    The directive applies to In-Vitro Diagnostic Medical Devices and their accessories. Whereas it is assumed that accessories shall be treated as In-Vitro Diagnostic Medical Devices in their own right.
    Certain devices are excluded from the scope of the directive.  According to Article 1 of the directive, a decision whether a device is within the scope of the directive will depend upon the intended purpose of the device and the claims for it.

    “For research use only” devices are not usually considered to be IVD medical devices.  This means that the device must have no medical intended purpose, no medical objective and it should not have a performance evaluation function.

    IVDD 98/79/EC | Structure | Scope | Compliance | IVDD 98/79/EC Services

    Each In-Vitro Device manufacturer must develop their own compliance program which addresses their particular device categories and business needs. The following are general steps to compliance:

    • Determination of the applicable standards (European, International or National)
    • Assessment and classification of your device (depending on the specific function of an In-Vitro Diagnostic Medical Device and whether or not it is listed in Annex II)
    • Identification of the appropriate conformity assessment module according to your device classification
    • Preparation of a “Technical File” including a user manual (Annex III, section 3)
    • Implementation of “Quality Assurance System” (Annex III, section 4)
    • Selection of a Notified Body within the European Economic Area to perform the official conformity assessment tasks
    • Preparation of an “EC Declaration of Conformity”
    • Affixing of the CE Marking in accordance with the directive

    For non-EU manufacturers: Appoint a European Authorized Representative established within the European Community

    The European Standards that are presumed by the European Commission to provide technical definition for demonstrating conformance to the “essential requirements” in the directive are published in the “Official Journal of the European Community”. While other national, regional or international standards can be used as well, European Standards are preferred since they are presumed by the European Commission to address the “essential requirements” contained in the directive.

    Manufacturers should test your device, determine its conformance to the appropriate legal requirements and construct a corresponding Technical File that should be available in the European Economic Area. Manufacturers also need to affix the required “CE Marking” Logo to the device before placement in the market. In many cases, manufacturers can self-certify that their devices meet the legal requirements contained in the directive. In most instances, such a self-certification requires the use of European Standards. 

    The “Declaration of Conformity” must be prepared and must contain the following information:

    • The manufacturer’s name and full address, telephone, fax numbers and e-mail
    • The European Directive complied with
    • Device identification
    • Standards used to verify compliance with the directives
    • Name of “Notifying Body” and its identification number
    • The “Authorized Representative’s” name and full address, telephone, fax numbers and e-mail

    The “Declaration of Conformity” and the “Technical Files” need only be written in “English”. However, instruction manuals need to be in the local language of the end user.

    The European Competent Authorities are the local regulating bodies in each member state responsible for fulfilling the obligations of market control. All IVDs require notification to the Competent Authorities and a European Authorized Representative for each device placed on the market. The Notified Body will issue the appropriate certification after an exhaustive assessment to ensure that all relevant requirements have been met. Subsequently, manufacturers can place the CE marking on their devices demonstrating their compliance with the requirements.

    Notification procedure for IVDs:

     

  • Any manufacturer who places a device on the European market has to notify the competent authorities of each Member State concerned by that placing on the market
  • For non-EU manufacturers:

    • This action can only be completed through a designated European Authorized Representative who will notify the competent authorities of that placing on the European Economic Area,
    • European Authorized Representative will then equip a non-EU manufacturer with “A certificate of CE Registration” which will demonstrate the submission of files to the European Authorities. From this point a non-EU manufacturer may place the device on the market
    • For a breakdown of the notification process

    For non-EU manufacturers: Appoint a European Authorized Representative established within the European Community.

    For the full flow chart for compliance with the IVD Directive, please click here.

    Non-Compliance

    The directive portrays European Law enforced within the EEA; non-compliance with the directive’s requirements will result in the removal of the device from the market and the revoking of the CE marking affixed on the device.



    IVDD 98/79/EC | Structure | Scope | Compliance | IVDD 98/79/EC Services

    The IVDD is one of the most complex of the EU’s “new approach” directives. It has 24 Articles and 10 Annexes. The Articles cover general items such as scope and definitions, placing devices on the market and putting them into service, free movement of CE marked goods in the European Economic Area, reference to harmonized standards, vigilance and incident reporting, conformity assessment procedures, registration responsibilities, appointment of an Authorized Representative, consequences of wrongly affixed CE marking, confidentiality, etc.

    In-Vitro Diagnostic Medical Devices are classified into three main groups:

    1. General IVD Medical Devices
    2. IVD Medical Devices from Annex II - List A and List B of the In-Vitro Diagnostic Medical Device Directive
    3. IVD Medical Devices for ‘self-test’ intended to be used by a lay person in the home environment

    Annex I- lists the Essential Requirements. All devices must comply with these requirements (where applicable). Manufacturers are required to check each device type or model against each requirement, determine whether the requirement is applicable, acquire documented evidence of compliance and keep this evidence available in the Technical File of the device. There are good reasons to say that Annex I is the real core of the directive.

    Annex II - lists devices of high or moderate risk, and is divided into two lists:
    List A: Reagents and reagent devices, including related calibrators and control materials for determining the following blood groups: ABO system, rhesus (C,c,D,E,e) anti-Kell; the detection, confirmation and quantification in human specimens of markers of HIV 1 and 2, HTLV 1 and II and Hepatitis B, C and D.
    List B: Reagents and reagent devices, including related calibrators and control materials for determining the blood groups Anti-Duffy and Anti-Kidd; determining irregular and antierythrocytic antibodies; detection and quantification of the infectious rubella and toxoplasmosis; diagnosing phenylketonuria; determining the infectious cytomegalovirus and chlamydia; HLA tissue groups DR,A,B; tumor marker PSA; evaluating the risk of trisomy 21(including software). Devices for self-diagnosis and measurement of blood sugar (glucose).
    Annex III - EC Declaration of Conformity. A procedure in which the manufacturer declares conformity of his devices with the IVDD. Applicable to all devices except those listed in Annex II or devices for performance evaluation. All “ordinary” IVD devices can be CE marked using this “self-certification” route. Additionally, for devices for self-testing, a Notified Body shall carry out an examination of the design.
    Annex IV - Full Quality Assurance System. Applicable to all devices listed in Annex II and may be applied for devices for self-testing. Sections 4 and 6 of this Annex require that design examination and batch release by a Notified Body shall be carried out for Annex II/List A devices.
    Annex V - EC Type - examination. A procedure which involves examination and testing of representative samples of the device by the Notified Body and certification that the device meets the applicable essential requirements. Annex V can only be used in combination with Annex VI (batch verification) or Annex VII (quality assurance system approval).
    Annex VI - EC Verification. A procedure in which the Notified Body examines and tests every individual device or sample taken from a batch on a statistical basis.
    Annex VII - Production Quality Assurance. The Notified Body shall audit and certify the manufacture’s production quality system (which is usually based on EN46002 or ISO 13488 standards).
    Annex VIII - Devices for performance evaluation. This Annex describes procedures concerning devices for performance evaluation, i.e. devices intended by the manufacturer to be subject to performance evaluation studies in clinical laboratories or in other environments outside his own premises.
    Annex IX - Criteria for the designation of Notified Bodies.
    Annex X - Appearance of the CE mark.

    The specific function of an In-Vitro Diagnostic Medical Device and whether or not it is listed in Annex II will determine its classification.

    Devices listed in Annex II List A are considered the highest risk devices. They are then followed by those in Annex II list B, then self-tested and finally the ‘general’ IVD Medical Devices.

    ANNEX II: List of Devices referred to in Article 9(2) (3)

    List A

    Reagents and reagent devices, including related calibrators and control materials, for determining the following blood groups: ABO system, rhesus (C, c, D, E, e) anti-Kell, reagents and reagent devices, including related calibrators and control materials, for the detection, confirmation and quantification in human specimens of markers of HIV infection (HIV 1 and 2), HTLV I and II, and hepatitis B, C and D.

    List B

    1. Reagents and reagent devices, including related calibrators and control materials, for determining the following blood groups: Anti-Duffy and Anti-Kidd
    2. Reagents and reagent devices, including related calibrators and control materials, for determining irregular anti-erythrocytic antibodies
    3. Reagents and reagent devices, including related calibrators and control materials, for the detection and quantification in human samples of the following congenital infections: rubella, toxoplasmosis
    4. Reagents and reagent devices, including related calibrators and control materials, for diagnosing the following hereditary disease: phenylketonuria
    5. Reagents and reagent devices, including related calibrators and control materials, for determining the following human infections: cytomegalovirus, chlamydia
    6. Reagents and reagent devices, including related calibrators and control materials, for determining the following HLA tissue groups: DR, A, B
    7. Reagents and reagent devices, including related calibrators and control materials, for determining the following tumoral marker: PSA
    8. Reagents and reagent devices, including related calibrators, control materials and software, designed specifically for evaluating the risk of trisomy 21, the following device for self-diagnosis, including its related calibrators and control materials: device for the measurement of blood sugar



    IVDD 98/79/EC | Structure | Scope | Compliance | IVDD 98/79/EC Services

    Future

    The Machinery Directive has recently been modified - Directive 2006/42/EC of the European Parliament and of the Council of May 17, 2006 on machinery, and amending Directive 95/16/EC (recast)

    Date of application

    Directive 2006/42/EC was published on June 9, 2006. It came into force twenty days later on June 29, 2006. The Member States have until June 29, 2008 to adopt and publish the national laws and regulations transposing the provisions of the new directive into national law. The provisions of the new directive become applicable on December 29, 2009. Until that date, the provisions of the current Machinery Directive 98/37/EC continue to apply.

    Aim

    The aim of the Machinery Directive is extended, since construction-site hoists and cartridge-operated fixing and other impact machinery will no longer be excluded. The borderline between the machinery and the Low Voltage Directives are clarified. The distinction will no longer be made on the basis of the “main risk”. Instead, the new Machinery Directive lists six categories of electrical machinery that are subject to the Low Voltage Directive – for other electrical machinery, the safety objectives of the Low Voltage Directive apply for the electrical risks, but the obligations concerning conformity assessment and the placing on the market are governed by the Machinery Directive. The borderline with the Lifts Directive has also been clarified. The new text modifies the scope of the Lifts Directive so that lifts with
    a travel speed no greater than 0.15 m/s will be excluded from the Lifts Directive and will thus be subject to the Machinery Directive. The range of safety components subject to the Machinery Directive has been clarified. An indicative list of safety components is given in a new Annex. This list can be updated by the Machinery Committee to cover new machinery.

    Changes

    Extensive changes are especially prevalent with the conformity assessment procedure
    of Annex IV Machines.

    As under the current Machinery Directive, the conformity of most machinery will continue
    to be certified by the manufacturer himself. Manufacturers of Annex IV machinery will have a wider choice of procedure:

    • for Annex IV machinery designed according to harmonized standards covering all the relevant essential requirements, the manufacturer will be able to certify the conformity of the machinery himself;
    • for other Annex IV machinery, the manufacturer will be able to choose between EC type-examination by a Notified Body or approval by a Notified Body of his full quality assurance system.

    The new Machinery Directive includes an obligation for the Member States to monitor the performance of Notified Bodies and to withdraw or suspend the notification if a Body fails to carry out its duties properly.

    In the event that there are no harmonized EU standards or the product was not constructed under compliance of these standards, an EC Type Examination by a recognized test center is currently required. The new directive now opens up the option of self-certification for the manufacturer without the participation of a test center, if they have a quality assurance procedure in accordance with Annex X.

    • The basic safety and health requirements (Annex I) will in the future require a risk assessment by the manufacturer.
    • In the Machinery Directive 98/37/EC there are different procedures for proving the safety of machinery, exchangeable equipment, safety components, chains/ropes/belts for lifting purposes, card an shafts and load-carrying equipment. In the future the same machine regulations will also apply for these products. They will have to be distributed in the future with CE conformity assessment, Declaration of Conformity and the required user information.
    • The requirements for “part-machines” (also referred to as “incomplete machines”) have been re-formulated in the new version of the Machinery Directive. Until now a manufacturer declaration was sufficient, but in the future the manufacturer will also have to supply a declaration of incorporation, which must specify which requirements of the directive apply to the part-machine and have been complied with. Installation instructions must be provided with the machine’s documentation.
    • Lifting machinery with a speed of up to 0.15 m/s of the load carrier are subject to the Machinery Directive; with a speed of more than 0.15 m/s they are subject to the Lift Directive (if they are not covered by its rules of exception).
    • The delimitation of the Low Voltage Directive is no longer regulated as risk-related, but rather machinery-related.
    • Construction site lifts are subject to the Machinery Directive.
    • Instead of a “hazard analysis”, a risk assessment and “risk evaluation” are required.
    • Clearer delimitation of the Machinery Directive for the Low Voltage Directive.
    • Internal production controls for series machines (Annex VIII).
    • The validity of EC Type Examination certifications must be checked by the test center every 5 years. Manufacturers and test centers are obligated to retain the relevant technical documents for 15 years.

    The following is a list by category of cosmetic products which fall under the Cosmetics Directive.

    • Creams, emulsions, lotions, gels and oils for the skin (hands face, feet, etc.)
    • Face masks (with the exception of peeling products)
    • Tinted bases (liquids, pastes, powders)
    • Make-up powders, after-bath powders, hygienic powders, etc.
    • Toilet soaps, deodorant soaps, etc.
    • Perfumes, toilet waters and eau de cologne
    • Bath and shower preparations (salts, foams, oils, gels, etc.)
    • Depilatories
    • Deodorants and anti-perspirants
    • Hair care products
    • Hair tints and bleaches
    • Products for waving, straightening and fixing
    • Setting products
    • Cleansing products (lotions, powders, shampoos)
    • Conditioning products (lotions, creams, oils)
    • Hairdressing products (lotions, lacquers, brilliantines)
    • Shaving products (creams, foams, lotions, etc.)
    • Products for making up and removing make-up from the face and the eyes
    • Products intended for application to the lips
    • Products for care of the teeth and the mouth
    • Products for nail care and make-up
    • Products for external intimate hygiene
    • Sunbathing products
    • Products for tanning without sun
    • Skin-whitening products
    • Anti-wrinkle products

    The Cosmetic Directive includes standards outlining what a cosmetic is defined as in order to be in the European Economic Area. The directive includes 15 Articles and 9 Annexes. The annexes range from lists of cosmetics to chemicals which are allowed in the cosmetics.

    Annex I-List by category of cosmetic products
    Annex II-Substances which should not be a part of cosmetic products
    Annex III-List of substances cosmetic products must not contain except subject to the conditions and regulations agreed upon
    Annex IV-List of colouring agents allowed in cosmetics
    Annex V-List of substances excluded from the scope of the directive
    Annex VI-List of preservatives that may be contained in cosmetics
    Annex VII-List of UV filters that cosmetic products may contain
    Annex VIII- Symbol for packaging
    Annex IX-List of validated alternative methods to animal testing

    In order to ensure that a cosmetic product complies with the Cosmetics Directive, the following steps must be taken:

    • Classification of the product - this includes making sure that the product is viewed as a cosmetic product by EU regulation, ensuring its safety for use and identifying the relevant laws applicable to the cosmetic product
    • Appoint a European Authorized Representative – the Cosmetics Directive requires an EU representative for non-European manufacturers of cosmetic products who wish to sell within the European Economic Area. An E.A.R. is responsible for placing the product on the market and keeping the product information available to the relevant competent authority. It is also the primary contact for EU authorities.
    • Create technical file – this must include the qualitative and quantitative composition of the product, physic-chemical and micro-biological specifications of the raw materials and the finished product and the methods of manufacture.
    • Prepare a safety assessment – this must show that the product is safe for human use under normal conditions, and must include the name and address of the qualified persons responsible for this assessment.
    • Labelling and language requirements – the name and address of the manufacturer, the nominal content, date of minimum durability, precautions for use, a batch number, the product’s name and function and ingredients.
    • Notify the product to Competent Authorities and Toxic Centres – this may be implemented differently by different EU Member State laws.

    For non-EU manufacturers: Appoint a European Authorized Representative established within the European Community.

    Non-Compliance

    The directive portrays European Law enforced within the European Economic Area (EEA); non-compliance with the directive’s requirements will result in the removal of the product from the EEA.

     

     

    Directives that amended the 93/42/EEC:

    a) Implementation:
    MD manufactured utilizing tissues of animal origin:

    • Directive 2003/32/EC - OJ L105/18- 26.04.2003
    • Reclassification of hip, knee and shoulder joint replacements:
    • Directive 2005/50/EC - OJ L 210 , 12/08/2005
    • Reclassification of breast implants:
    • Directive 2003/12/EC - OJ L028/ 4.02.2003

    b) Directive 2007/47/EC:

    The new directive 2007/47/EC has implications not only for manufacturers who sell medical devices in the EU but for the medical device industry as a whole.
    (I)The directive 2007/47/EC amends the following directives: AIMDD 90/385/EEC, MDD 93/42/EEC and the directive 98/8/EC concerning the placing of biocidal products in the European Economic Area. Manufacturers will need to be aware of several essential changes in order to ensure compliance with these new EU regulations.

    1. First and foremost, manufacturers are required to designate a European Authorized Representative for all classes of medical devices and the same one for the same category of medical devices (“single authorized representative”). The Authorized Representative is appointed by the manufacturer and deals with the compliance of devices in relation to the directives.
    2. Devices will now be classified by their primary mode of action and not by intended use.
    3. Manufacturers of Class I sterile and/or measuring medical devices will be given the option of using the full quality assurance conformity assessment module allowing more flexibility when choosing a compliance route.
    4. Software intended for use by the manufacturer for medical purpose(s) is confirmed as a medical device. Furthermore, if the software is a stand alone or is incorporated in a device the validation of the software is required.
    5. Clinical data is required for ALL devices regardless of classification
    6. Custom-device manufacturers are subject to a post market production review system involving incident reporting to the authorities.
    7. Manufacturers must retain their records for 5+ years for the competent authorities and manufacturers of implantable devices for 15 years for administrative purposes.
    8. Manufacturers who use third parties to carry out the design and manufacturing of devices must demonstrate that the controls are adequately applied to the third party to ensure efficient quality system operation.
    9. Explicit prior authorization concerning conformity and an assessment of the design documentation is required for Class III devices to be placed on the market. It is necessary that the Notified Body reviews the design documentation for the medical device(s) to ensure proper compliance.
    10. All surgically invasive devices intended specifically to control, diagnose, monitor or correct a defect of the heart or of the central circulatory system through direct contact with these parts of the body are classified as Class III devices. The definition of the central circulatory system has now been expanded (see Annex X).
    11. Regulatory data in accordance with this directive shall be stored in a European databank accessible to the competent authorities. This regulatory data includes information on registration, vigilance reports and certificates as well as data relating to clinical investigations. The data should be forwarded in a standardized format (Article 10b).
    12. Devices that use human tissue, blood and plasma will fall under the scope of directive 2001/83/EC and will be classified as Class III.
    13. Manufacturers must now clearly indicate the date of issue or the latest revision of the instructions for use.
    14. Manufacturers must provide information on known characteristics and technical factors known to the manufacturer that could pose a risk if the device were to be re-used. A manufacturer’s indication of single use must be consistent across the EU and the information must be made available to the user upon request.
    15. Where a relevant hazard exists, devices which are also machinery within the meaning of Article 2(a) of Directive 2006/42/EC of the European Parliament and of the Council of the May 17, 2006 on machinery (5) shall also meet the essential health and safety requirements set out in Annex I to that directive to the extent to which those essential health and safety requirements are more specific than the essential requirements set out in Annex I to this directive.


    The new directive modifies several key issues regarding medical devices and amends three significant medical device directives. It is important that manufacturers understand their new responsibilities to guarantee their proper compliance in the EU. Obelis European Authorized Representative Center (O.E.A.R.C.) not only serves as an authorized representative for non-EU manufacturers but also helps make sure manufacturers are as up to date as possible regarding essential changes to the directives.

    (II) European Authorized Representative role requirement re-enforced.

    4 amendments concerning the MDD 93/42/EEC and 1 concerning the AIMDD 90/385/EEC were more particularly adopted regarding the requirement of appointing a European Authorized Representative.

    “It is necessary to introduce an obligation for such manufacturers to designate an authorized representative for all classes of devices: The obligation for a non EU manufacturer to appoint an EC REP for all classes of medical devices.” Amendment 18 Recital 14. Comment: A major clarification confirming the obligation of non EU manufacturers who do not have a legal identity within the EU territory for all classes of medical devices to appoint an EC REP.

    “The authorized representative should also be available for any queries” (from the EU Member States Competent Authorities) Amendment 19, Article 1, point 3 - Article 10a, paragraph 2, subparagraphs 2 (AIMDD 90/385/EEC). Comment: The confirmation of the role and duty of the EC REP as (Vigilance) contact point with the EU Member States Competent Authorities.

    “Where a manufacturer who places a device on the market under his own name does not have a registered place of business in a Member State, he shall designate for this device a single authorized representative in the European Union”. Amendment 42 Article 2, Point 7 - Article 14, paragraph 2, subparagraph 1 (MDD 93/42/EEC. Comment: The confirmation of the obligation for a non EU Manufacturer to appoint 1 single EC REP for a product (but the manufacturer does not need necessarily to designate the same EC REP for his entire range of medical devices)

    “As regards reprocessing, manufacturers and/or authorized representatives must declare their products uniformly within the European Union.”. The manufacturer and/or his representative shall provide a detailed documentation on how the device can be safely reprocessed.” Amendment 59 Annex II Point I (A A) - Annex I, Section 6a (new) (MDD 93/42/EEC). Comment: Besides the fact that it shows very clearly the responsibility of the manufacturer regarding the classification of the usage of their medical devices and the requirement of a clear justification when the device is designed for single use, this amendment makes very clear the role and duty of the appointed EC REP in regards to making available such justification documents to the EU Member States Competent Authorities.

    “The manufacturer must prepare the technical documentation described in Section 3. The manufacturer or his authorized representative established in the Community or the importer must make this documentation, including the declaration of conformity, available to the national authorities for inspection for a period of at least five years from the date of manufacture.” Amendment 70 Annex II, Point 7 (A) - Annex VII, section 2 (MDD 93/42/EEC) Comment: The aim of this last amendment is to reinforce the availability of the technical documentation to the EU Competent Authorities. Although a single authorized representative has to be designated, making the documentation available to the Competent Authorities, the EU still gives an additional way of getting this crucial information by adding the importer “into the loop”.

    Amendment 70 Annex II, Point 7 (A) - Annex VII, section 2 (MDD 93/42/EEC) Comment: The aim of this last amendment is to reinforce the availability of the technical documentation to the EU Competent Authorities. Although a single authorized representative has to be designated, making the documentation available to the Competent Authorities, the EU still gives an additional way of getting this crucial information by adding the importer “into the loop”.

    The EU Commission released a “consolidated version” of the MDD 93/42/EEC available from website library (Please note that a “consolidated version” has no legal validity as only the above mentioned directives adopted by the EU parliament have)

    MDD 93/42/EEC | Structure | Scope | Compliance | Custom made devices | Kits | Amendment 2007/47/EC | Clinical Investigation of the MDD 93/42/EEC | MDD 93/42/EEC Services

    MDD 93/42/EEC (Medical Device Directive), amended by the 2007/47/EC, requires clinical data and an evaluation of that data to ensure the safety of the medical device. Clinical data is collected or generated from the clinical use of the device and observing the performance of this device and its safety. The following activities allow for obtaining this data:

    • Published data on clinical experience with the device or equivalent
    • Clinical investigation
    • Clinical investigation with similar device
    • Combination of the above

    The medical devices must go through clinical evaluation which is the process of assessing clinical data and making sure that the data is in conformity with the harmonized standards and essential requirements that have been established by the European Union. This clinical evaluation proves that the device is safe and performs according to its intended purpose established by the manufacturer.

    The clinical evaluation must follow a certain procedure based on either.

    a) The relevant scientific literature currently available evaluating the design characteristics, safety, and performance of the device all based on its intended use where:
    - there is demonstration of equivalence of the device to the device to which the data relates and
    - the data adequately demonstrates compliance with the relevant essential requirements
    b) A critical evaluation of results of all clinical investigations made
    c) Critical evaluation of data of the combined clinical data provided by literature and clinical investigation.

    When a clinical evaluation is not appropriate, there must be adequate justification based on risk management output and under consideration of the specifics of the device/body interaction, the performances intended and claims of the manufacturer. Clinical evaluation also is focused on those elements of safety and/ or performance that could not be based on laboratory testing. Medical Device Directive Annex VIII requires that all clinical testing has been performed properly.

     

    Manufacturer’s responsibility

    Clinical investigation is the systematic study or investigation of safety and performance of a device being used by human beings in accordance with the device’s normal use.

    Manufacturer is responsible for the:

    • Design of the study
    • Designation of principal investigator
    • Application with ethical committee
    • The non-EU manufacturer may choose to appoint an Authorized Representative to complete the notification of the clinical investigation to the relevant EU Member State competent authority
    • Incident Reporting-in the event of an incident during the clinical investigation, the reporting as such will need to be determined and performed by the appointed Authorized Representative
    • Documentation available-the clinical investigation data (reports) should be incorporated in the technical documentation that has to be kept available by the manufacturer of his appointed European Authorized Representative established within the Community

    Clinical Investigation plan:
    – Clear measurable objectives
    – Criteria to stop the trial
    – Statistical power
    – Patient population equivalent to EU

    The clinical evaluation and its documentation must continually be updated by its post-market surveillance information. If this post-market surveillance is not needed for some reason in following up on the medical device, an acceptable justification must be given and documented. For high risk devices, there must be a clinical follow-up report given with the final report.

    Role of the Competent Authority

    Approval to begin process of investigation

    • Some countries require 60 days
    • Other countries allowed to begin right upon submission of request

    There must also be a registration in the European Databank.

    Role of the European Notified Body

    Investigation must be reviewed by the Notified Body who has such authority.

    • Assessment of clinical safety and performance
    • Conclusion with justification



    MDD 93/42/EEC | Structure | Scope | Compliance | Custom made devices | Kits | Amendment 2007/47/EC | Clinical Investigation of the MDD 93/42/EEC | MDD 93/42/EEC Services

    For Flow charts to compliance - click here

    Classes

    The Medical Device Directive establishes in Annex IX the different classifications for devices.

    • Class I-Devices low risk such as stethoscopes, bandages, etc. The devices are non-evasive. The manufacturer must complete a technical file.
    • Class I sterile-Devices are low risk such as stethoscopes, bandages, etc. The devices are non-evasive. The manufacturer must complete a technical file and apply to a European Notified Body to get certified in the area of manufacturing dealing with sterility.
    • Class I measuring- Devices are low risk such as stethoscopes, bandages, etc. The devices are non-evasive. The manufacturer must complete a technical file and apply to a European Notified Body to get certified in the area of manufacturing dealing with metrology.
    • Class IIa-Devices low-medium risk devices such as a hearing-aid. Devices that are within the body between 60 minutes and 30 days fall within this class. This class also warrants technical files as well as having a European Notified Body perform a conformity test.
    • Class IIb-Devices are medium-high risk. The devices in this class are in the body more than 30 days. Examples include ventilators and intensive care monitoring equipment. Compliance route is the same as Class IIa with an additional step of type examination of the device by the European Notified Body.
    • Class III-These are high-risk devices. Some examples are balloon catheters and prosthetic heart valves. The steps to approval are audit of the full quality assurance system and examination of the design by the European Notified Body examination and testing of the device.

    18 Rules of Classification

    • Rule 1 – Devices that either do not touch the patient or contact intact skin only
    • Rule 2 – Channeling or storing for eventual administration
    • Rule 3 – Devices that modify biological or chemical composition of blood, body liquids or other liquids
    • Rule 4 – Devices in contact with injured skin
    • Rule 5 – Devices invasive in body orifices
    • Rule 6 – Surgically invasive devices for transient use except if there are reusable surgical instruments.
    • Rule 7 – Surgically invasive devices for short term use
    • Rule 8 – Surgically invasive devices for long term use and implantable devices
    • Rule 9 – Active therapeutic devices intended to exchange or administer energy
    • Rule 10 –Active devices for diagnosis
    • Rule 11 – Active devices to administer, remove medicines and other substances to or from the body
    • Rule 12 – All other active devices
    • Rule 13 – Devices incorporating a medicinal substance
    • Rule 14 – Devices used for contraception or prevention of sexually transmitted diseases.
    • Rule 15 – Specific disinfecting, cleaning and rinsing devices
    • Rule 16 – Non-active devices to record X-ray diagnostic images
    • Rule 17 – Devices utilizing animal tissues or derivatives
    • Rule 18 – Blood bags

    For non-EU manufacturers: Appoint a European Authorized Representative established within the European Community.

    These images show the full flow chart for compliance. Click to enlarge

    Compliance with the Class I devices:


    Compliance with the Class I sterile devices:


    Compliance with the Class I measuring devices:


    Compliance with the Class IIa devices:


    Compliance with the Class IIb devices:


    Compliance with the Class III devices:


    Non-Compliance

    The directive portrays European Law enforced within the European Economic Area (EEA); non-compliance with the directive’s requirements will result in the removal of the device from the EEA and the revoking of the CE marking affixed on the device.

    MDD 93/42/EEC | Structure | Scope | Compliance | Custom made devices | Kits | Amendment 2007/47/EC | Clinical Investigation of the MDD 93/42/EEC | MDD 93/42/EEC Services

    The MDD 93/42/EEC amended by the 2007/47/EC consists of 22 Articles and 12 Annexes. The Articles define what a medical device is characterized according to the directive as well as the harmonized standards that the devices must meet. The Annexes list the general requirements to EC Verification.

    Annex I- Lists and explains the essential requirements of the directive.
    Annex II- Outlines the full quality assurance system or the EC Declaration of Conformity
    Annex III-EC Type Examination outlined
    Annex IV-Explains EC Verification
    Annex V-EC Declaration of Conformity in reference to the production quality assurance
    Annex VI-EC Declaration of Conformity in reference to device quality assurance
    Annex VII-EC Declaration of Conformity process explained
    Annex VIII-A statement concerning devices for special purposes
    Annex IX-Classification criteria given
    Annex X-Clinical Evaluation procedure documented
    Annex XI-Criteria to be met for the designation of Notified Bodies
    Annex XII-CE marking of conformity

    MDD 93/42/EEC | Structure | Scope | Compliance | Custom made devices | Kits | Amendment 2007/47/EC | Clinical Investigation of the MDD 93/42/EEC | MDD 93/42/EEC Services

obelis people image

Client Access

Old system login



New system login

Search


International Markets






GiDoS - Green Regulatory Center

Our sister company GiDoS s.p.r.l. provides REACH, WEEE, RoHS and P&PW compliance services.
Visit GiDoS.net

Newsletter

» Sign up for our newsletter to receive our weekly publications on EU directives, our news and events, as well as updates to our web site.

Follow us:

           

Career Opportunities