European Directives

• Updated on Aug 23, 2009

  RoHS 2002/95/EC

  The Restriction of the use of certain Hazardous Substances specifies maximum levels for use of 6 restricted hazardous substances in the manufacture of various types of Electrical and Electronic Equipment (EEE). RoHS coincides with the WEEE Directive as part of a legislative initiative to solve the problems and risks associated with …. » more
• Updated on Apr 22, 2009

  General steps for TSD CE Marking

  Each Device Manufacturer must develop their own compliance program which addresses their particular product categories and business needs. We suggest you contact Obelis (O.E.A.R.C.) for steps tailored to your product. It is important to select your European Authorized Representative before choosing an Approved Body (Notified Body); particularly to assist you in …. » more
• Updated on Apr 22, 2009

  Toy Safety Directive 88/378/EC Notified Bodies

  Notified Bodies are the organizations approved by the national government of their member state as being competent to make an independent judgment about whether or not a product complies with the essential requirements laid out in a European Directive. . » more
• Updated on Nov 11, 2008

  TSD Competent Authorities

  RAPEX serves as a single European rapid alert system for dangerous consumer products. All non-food products intended for consumers or likely under reasonably foreseeable conditions to be used by consumers are included within the scope of RAPEX, with the exception of pharmaceutical and medical products. RAPEX CONTACT POINTS. » more
• Updated on Apr 22, 2009

  The Structure of the Toy Safety Directive 88/378/EEC

  The Toy Safety Directive 88/378/EEC has 16 Articles and 4 Annexes. The Articles cover general items such as scope and definitions, placing products 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, …. » more
• Updated on Nov 11, 2008

  Toy Safety Directive Need of CE Marking

  The European Commission does not publish a list of products to which their laws apply. Rather, they require the Manufacturer to determine the applicability of Directives to their product. The European Standards that are presumed by the European Commission to provide technical definition for demonstrating conformance to the “essential requirements” in …. » more
• Updated on Apr 22, 2009

  Non European Toy Directive 88/378/EEC Manufacturers

  The European Commissions’ directive concerning the safety of toys, 88/378/EEC, has been in force since 1 January 1990. The Toy Safety Directive (TSD), as it is commonly called, is designed to protect consumer health for users and 3rd parties who may not use the “same degree of care as the average …. » more
• Updated on Apr 22, 2009

  PPE: Need of CE marking

  It is left up to the Manufacturer to determine the applicability of the Directives to their product as well as the product classification. Determining whether your product needs CE Marking requires familiarity with the 89/686/EEC European Directives’ definition of Category I, Category II, and Category III Equipment. Personal Protective Equipment is …. » more
• Updated on Nov 11, 2008

  PPE: Competent Authorities

  RAPEX The Rapid Exchange notification system is the official system by which consumers, manufacturers, distributors, and officials notify member states of dangers posed by consumer products. The contact point for each member state is listed in the following PDF file. . » more
• Updated on Apr 22, 2009

  PPE: 89/686/EEC Structure

  89/686/EEC concerning Personal Protective Equipment (PPE) has 17 Articles and 6 Annexes. Originally published in 1989, the PPE directive only has 3 Modifications 93/95/EEC, 93/68/EEC, and 96/58/EEC. The Introduction establishes the focus of the directive as ‘safeguarding of public health, improving safety at work and ensuring user protection’ and reinforces the …. » more
• Updated on Apr 22, 2009

  Personal Protective Equipment 89/686/EEC Notified Body

  To establish and certify that Personal Protective Equipment meets the relevant requirements of the PPE 89/686/EEC directive, Personal Protective Equipment in categories II and III must be submitted to an ‘approved inspection body’ for an EC type examination. (89/686/EEC Art.10, 1-2) Here you will find a current list of approved Notified …. » more
• Updated on Apr 22, 2009

  Steps to obtain CE Marking for your PPE 89/686/EEC Directive Products

  Every Personal Protective Manufacturer must develop their own compliance program which addresses their particular product categories and business needs. We suggest you contact Obelis European Authorized Representative for steps tailored to your company. It is important to select your European Authorized Representative before choosing a Notified Body; particularly before categorizing your …. » more
• Updated on Apr 22, 2009

  Non European Personal Protective Equipment Manufacturers 89/686/EEC

  The 89/686/EEC Personal Protective Equipment (PPE) Directive covers requirements for all Safety Equipment from fire proof footwear to gardening gloves. Since December 31,1991, Directive 89/686/EEC requires Non-European Personal Protective Equipment Manufacturers to appoint a European Authorized Representative (PPE 89/686/EEC Art 8. 1). Obelis (O.E.A.R.C.) is the foremost Authorized Representative for your …. » more
• Updated on Apr 22, 2009

  Notified Bodies for Machinery Directive 98/37/EC

  Please find below the list of Notified Bodies for Machinery Directive 98/37/EC in PDF format, available for download now. Machinery Directive Notified Bodies PDF. » more
• Updated on Apr 22, 2009

  Steps to obtain CE Marking for your Machinery Directive 98/37/EC Product

  Each Manufacturer must develop their own compliance program which addresses their particular product categories and business needs. We suggest you contact Obelis European Authorized Representative for steps tailored to your company. It is important to select your European Authorized Representative before choosing a Notified Body; Particularly in assisting you with the …. » more
• Updated on Apr 22, 2009

  The Structure of the Machinery Directive 98/37/EC

  The Machinery Directive is one of the most extensive of the European Commissions “New Approach” directives. It has 16 Articles and 7 Annexes. The Articles cover general items such as the scope and definitions, placing products on the market and putting them into service, free movement of CE marked goods in …. » more
• Updated on Feb 21, 2009

  List of Notified bodies under Directive 98/73/EC Machinery

  . » more
• Updated on Apr 22, 2009

  MDD: Conformity Assessment Procedures

  Follow the links below to find out more about Conformity Assessment Procedures of the Medical Device Directive CLASS I: non sterile devices CLASS I: sterile & measuring function device CLASS IIa CLASS IIb CLASS III. » more
• Updated on Dec 28, 2008

  MDD - IVD: Need of CE Marking

  As non-European Medical Devices Manufacturers exporting to Europe, do your products require CE-Marking? It is left up to the Manufacturer to determine the applicability of the Directives to their product as well as the product classification. Determining whether your product needs CE Marking or not requires some familiarity with the European …. » more
• Updated on Apr 22, 2009

  Steps to obtain CE Marking for your MDD product

  Each Medical Device Manufacturer must develop their own compliance program which addresses their particular product categories and business needs. We suggest you contact Obelis (O.E.A.R.C.) for steps tailored to your company. It is important to select your European Authorized Representative before choosing a Notified Body; Particularly in assisting you classifying your …. » more
• Updated on Dec 28, 2008

  Competent Authorities for Medical Device Directive 93/42/EEC

  The European Competent Authorities are the local regulating bodies in each member state responsible for fulfilling the obligations of market control. Most European directives require notification to the Competent Authorities and a European Authorized Representative for each product placed on the market. MDD Competent Authorities list. . » more
• Updated on Dec 27, 2008

  The Structure of the Medical Device Directive 93/42/EEC

  The MDD is one of the most complex of the EU’s “new approach” directives. It has 23 Articles and 12 Annexes. The Articles cover general items such as scope and definitions, placing products on the market and putting them into service, free movement of CE marked goods in EU, reference to …. » more
• Updated on Dec 28, 2008

  List of Bodies Notified Under Directive: 93/42/EEC Medical devices

  The list of notified bodies for directive 93/42/EEC Medical devices can be downloaded below in PDF format Download MDD-notified_body.pdf as PDF. » more
• Updated on Nov 26, 2008

  MDD Class I: Non Sterile Devices

  . » more
• Updated on Nov 26, 2008

  MDD Conformity Assessment Class II A

  . » more
• Updated on Nov 26, 2008

  MDD-Conformity-Assessment-Class II B

  . » more
• Updated on Nov 26, 2008

  MDD-Conformity Assessment-Class III

  . » more
• Updated on Nov 26, 2008

  Class I: Sterile and Measuring Function Device

  . » more
• Updated on Nov 10, 2008

  MDD 93/42/ECC Annex VI excerpt

  EC Declaration Of Conformity (product Quality Assurance) 1. The manufacturer must ensure application of the quality system approved for the final inspection and testing of the product, as specified in Section 3 and must be subject to the surveillance referred to in Section 4. In addition, for products placed on the …. » more
• Updated on Nov 10, 2008

  MDD 93/42/ECC Annex VIII excerpt

  1. The EC declaration of conformity is the procedure whereby the manufacturer or his authorized representative established in the Community who fulfills the obligations imposed by Section 2 and, in the case of products placed on the market in a sterile condition and devices with a measuring function, the obligations imposed …. » more
• Updated on Nov 10, 2008

  MDD 93/42/ECC Annex I 13.3 excerpt

  13.3. The label must bear the following particulars: (a) the name or trade name and address of the manufacturer. For devices imported into the Community, in view of their distribution in the Community, the label, or the outer packaging, or instructions for use, shall contain in addition the name and address …. » more
• Updated on Nov 10, 2008

  Update Medical Devices Directive 93/42/EEC - Clinical Evaluation

  Update Medical Devices Directive 93/42/EEC - Clinical Evaluation In reference to the recent changes to the MDD 93/42/EEC by its amendment the 2007/47/EC, the following needs to be brought to your attention: 1. All classes of Medical Devices will require “clinical data”. 2. Confirmation of conformity must be based on clinical …. » more
• Updated on Nov 10, 2008

  MDD 93/42/ECC Article 4.4 excerpt

  4. Member States may require the information, which must be made available to the user and the patient in accordance with Annex I, point 13, to be in their national language(s) or in another Community language, when a device reaches the final user, regardless of whether it is for professional or …. » more
• Updated on Apr 22, 2009

  LVD: General steps

  Each Low Voltage Electrical Equipment Manufacturer must develop their own compliance program which addresses their particular product categories and business needs. We suggest you contact Obelis (O.E.A.R.C.) for steps tailored to your company. Appoint Obelis European Authorized Representative as your “European Authorized Representative” within the EU. Obelis European Authorized Representative will …. » more
• Updated on Nov 10, 2008

  LVD: 72/23/EEC Structure

  73/23/EEC (LVD) concerning Low Voltage Electrical Equipment currently has 14 Articles and 4 Annexes. One of the oldest European directives, it was originally published in 1973 and has only one modification, 93/68/EEC, published 22 July 1993. The Articles cover general items such as: definitions, basic safety requirements, quality practices, Market Obstruction, …. » more
• Updated on Nov 10, 2008

  LVD: Need of CE marking

  Low Voltage Electrical Equipment is “any equipment designed for use with a voltage rating of between 50 and 1000 v for alternating current and between 75 and 1500 v for direct current.” 73/23/EEC. The European Commission does not publish a list of products to which their laws apply. Rather, they require …. » more
• Updated on Dec 28, 2008

  Low Voltage Directive 73/23/EEC Notified Bodies

  Notified Bodies are the organizations approved by the national government of their member state as being competent to make an independent judgment about whether or not a product complies with the essential requirements laid out in a European Directive. EU LVD Notified Bodies. RAPEX serves as a single European rapid alert …. » more
• Updated on Nov 10, 2008

  Steps to obtain CE Marking for your IVD product

  Each In Vitro Device Manufacturer must develop their own compliance program which addresses their particular product categories and business needs. We suggest you contact Obelis (O.E.A.R.C.) for steps tailored to your company. The following are general steps to obtain CE Marking. Appoint Obelis European Authorized Representative Center (O.E.A.R.C.) as your “European …. » more
• Updated on Nov 10, 2008

  IVD: Need of CE Marking

  The European Commission does not publish a list of products to which their laws apply. Rather, they require the Manufacturer to determine the applicability of Directives to any given product. We would suggest to you to use such “Competent Laboratory” to prepare your “Declaration of Conformity” whether your products do or …. » more
• Updated on Nov 26, 2008

  IVD: Conformity Assessment Procedures

  Click to enlarge . » more
• Updated on Dec 28, 2008

  In Vitro Diagnostic Directive(IVD) 98/79/EC Annex II

  Official Journal of the European Communities L 331 , 07/12/1998 p. 0001 - 0037 ANNEX II : LIST OF DEVICES REFERRED TO IN ARTICLE 9(2) (3) List A Reagents and reagent products, including related calibrators and control materials, for determining the following blood groups: ABO system, rhesus (C, c, D, E, …. » more
• Updated on Dec 28, 2008

  The Structure of the IVD Directive 98/79/EC

  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 products on the market and putting them into service, free movement of CE-marked goods in EU, reference to harmonized …. » more
• Updated on Nov 10, 2008

  Competent Authorities for the In Vitro Diagnostic Directive 98/79/EC

  The European Competent Authorities are the local regulating bodies in each member state responsible for fulfilling the obligations of market control. Most European directives require notification to the Competent Authorities and a European Authorized Representative for each product placed on the market.  IVD Competent Authorities list.. » more
• Updated on Dec 28, 2008

  Notified Bodies for the In Vitro Diagnostics Directive 98/79/EC Products

  The list of Notified Bodies for the In Vitro Diagnostics 98/79/EC can be downloaded below in PDF format . Download: In Vitro Diagnostics 98/79/EC Notified Bodies. » more
• Updated on Nov 10, 2008

  IVD 98/79/EC Annex IV excerpt

  EC Declaration Of Conformity (Full Quality Assurance System) 1. The manufacturer must ensure application of the quality system approved for the design, manufacture and final inspection of the devices concerned, as specified in section 3, and is subject to audit as laid down in section 3.3 and to the surveillance as …. » more
• Updated on Nov 10, 2008

  IVD 98/79/EC Annex III excerpt

  1. The EC declaration of conformity is the procedure whereby the manufacturer or his authorised representative who fulfils the obligations imposed by section 2 to 5 and additionally, in the case of devices for self-testing, the obligations imposed by section 6, ensures and declares that the products concerned meet the provisions …. » more
• Updated on Nov 10, 2008

  IVD 98/79/EC Annex I § 8 excerpt

  8. Information supplied by the manufacturer. 8.1. Each device must be accompanied by the information needed to use it safely and properly, taking account of the training and knowledge of the potential users, and to identify the manufacturer. This information comprises the data on the label and in the instructions for …. » more
• Updated on Dec 27, 2008

  Non European In Vitro Diagnostic Medical Manufacturer

  The IVDD 98/79/EC In-Vitro Diagnostic Medical Devices Directive published on October 7, 1998 requires Non-European IVDD Manufacturers to appoint a European Authorized Representative to sell their product in Europe. (IVDD 98/79/EC Article 9.7) Obelis (O.E.A.R.C.) is the foremost Authorized Representative for your In-Vitro Diagnostic Devices. Published in October 7, 1998, the …. » more
• Updated on Nov 10, 2008

  IVD Annex II: List of Devices

  Official Journal of the European Communities L 331, 07/12/1998 p. 0001 - 0037. ANNEX II: LIST OF DEVICES REFERRED TO IN ARTICLE 9 (2) (3) List A Reagents and reagent products, including related calibrators and control materials, for determining the following blood groups: ABO system, rhesus (C, c, D, E, e) …. » more
• Updated on Nov 10, 2008

  General Product Safety Directive 2001/95/EC Competent Authorities

  DG SANCO DG Health and Consumer Protection’s goal is to promote a better quality of life for Europe’s citizens. The DG is responsible for ensuring a high level of protection of consumers’ health, safety and economic interests as well as of public health, issues relevant to daily life of European citizens …. » more
• Updated on Feb 17, 2009

  General Product Safety Directive 2001/95/EC

  The GPSD 2001/95/EC is designed to protect consumers from unsafe products. These harmonized standards and essential requirements must be met for products to be placed in the European Economic Area. Some examples of products that fall under this directive include sports equipment and household products. Specifically, any product that will be …. » more
• Updated on Nov 10, 2008

  Steps for complying with the General Safety Directive 2001/95/EC

  The European Council Directive 2001/95/EC on “General Products Safety” does not require the manufacturer to affix the CE-Marking on the product. The manufacturer should be aware that any use of a CE-Marking logo for products falling in a category of products that do not require the manufacturer to do so, is …. » more
• Updated on Dec 28, 2008

  Packaging and Packaging Waste

  The Directive 94/62/EC on Packaging and Packaging Waste is the continuing effort of the European Commission to minimize the impact of waste on the environment. 94/62/EC requires each member state to meet continually rising standards of recovery set forth by the European Commission. Since the burden of proving their compliance lies …. » more
• Updated on Nov 10, 2008

  EMC: Notified Bodies

  Notified Bodies Notified Bodies are the organizations approved by the national government of their member state as being competent to make an independent judgment about whether or not a product complies with the essential requirements laid out in a European Directive. EU EMC Notified Bodies. . » more
• Updated on Dec 28, 2008

  Equipment Emitting Electromagnetic Waves 89/336/EEC CE Marking Services

  The European Commission does not publish a list of products to which their laws apply. Rather, they require the Manufacturer to determine the applicability of Directives to their product. The European Standards that are presumed by the European Commission to provide technical definition for demonstrating conformance to the “essential requirements” in …. » more
• Updated on Nov 10, 2008

  EMC Workbook order form

  http://obelis.net/Services/Emc/emcform.php Suspendisse consectetuer nulla eget dui. Integer sem. Quisque pede ipsum, vehicula eu, vehicula eu, convallis eget, mi. In sollicitudin tincidunt odio? Aliquam fringilla nisl quis felis. Nunc consequat, odio id mollis sollicitudin, est nunc fermentum nisl, a ultrices elit quam ac erat. Praesent a justo ac pede vulputate blandit! Vestibulum …. » more
• Updated on Nov 26, 2008

  Equipment Emitting Electromagnetic Waves Competent Authorities

  Competent Authorities The European Competent Authorities are the local regulating bodies in each member state responsible for fulfilling the obligations of market control. Most European directives require notification to the Competent Authorities and a European Authorized Representative for each product placed on the market. Central Contact Points in charge of Market …. » more
• Updated on Dec 28, 2008

  EMC Marking and Labeling Workbook For Sale

  Are you developing or selling a medical product that: Has a new pre-market approval for the FDA ? Is CE marked to the Medical Device Directive (93/42/EEC) ? Falls under the Canadian Medical Regulations (SOR/98-282) ? If your product falls into any of these 3 categories, the 2nd Edition of …. » more
• Updated on Nov 10, 2008

  The Structure of the Electromagnetic Compatibility Directive 89/686/EEC

  The Electromagnetic Compatibility 89/686/EEC Directive has 12 Articles and 3 Annexes. The Articles cover general items such as scope and definitions, placing products 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, …. » more
• Updated on Apr 22, 2009

  Non-european manufacturers of equipment emitting electromagnetic waves

  The EMC 89/336/EEC on Electromagnetic Compatibility, mandatory since 1st January 1992, requires Non-European Manufacturers of electromagnetic wave emitting devices to appoint a European Authorized Representative to sell their product in Europe (EMC 89/336/EEC Art. 10, 1). Obelis European Authorized Representative provides superior quality “European Authorized Representative Services” backed by 16 years, …. » more
• Updated on Apr 22, 2009

  Steps to obtain CE Marking for your EMC Directive 89/336/EEC product

  Each Device Manufacturer must develop their own compliance program which addresses their particular product categories and business needs. We suggest you contact Obelis European Authorized Representative for steps tailored to your company. It is important to select your European Authorized Representative before choosing a Notified Body; particularly in assisting you in …. » more
• Updated on Nov 26, 2008

  Notification Procedure For Non-European Cosmetic Manufacturers

  . » more
• Updated on Nov 26, 2008

  Cosmetics Directive: Antitoxic centres

  Below is a list of antitoxic centres in Europe: Austria Vergiftungsinformationszentrale Allgemeines Krankenhaus Waehringer Geutel 18-20 A - 1090 Wien Tel (emergency): +43.1.406.43.43 Tel (administration): +43.1.404.00.22.22 Belgium Poisons Centre C/o Hôpital Militaire Reine Astrid Rue Bruyn B - 1120 Brussels Tel (emergency): +32.70.245.245 Tel (administration): +32.2.264.96.36 Bulgaria Department of Clinical Toxicology …. » more
• Updated on Nov 26, 2008

  Cosmetics Directive: Competent Authorities

  Below is a list of competent authorities relevant to the cosmetics directive: Austria Budeskanzleramt Gruppe VI/B Raderzkystraße 2 A-1031 Wien Belgium Ministère de la Santé Publique Inspection Générale des Denrées Alimentaires Quartier esplanade, 11° étage Boulevard Pachéco 19, bte 5 B- 1000 Bruxelles Denmark Produktregistret (Arbejstilsynet) Landskronagade 33w DK - 2100 …. » more
• Updated on Nov 26, 2008

  Non European Cosmetic 76/768/EEC Manufacturers

  Since the introduction of the Cosmetic Directive 76/768/EEC on June 30, 1999, a European Authorized Representative is required in order for non-European Cosmetic Device Manufacturers to sell their product in Europe. Obelis (O.E.A.R.C.) is the foremost Representative for your Cosmetic Products. Obelis European Authorized Representative provides superior quality “European Authorized …. » more
• Updated on Dec 28, 2008

  Non European Machinery, Subassembly and Component Manufacturers

  The Machinery Directive 98/37/EC, mandatory since 1st January 1995, covers machinery, sub-assemblies and safety components. In the interest of the safety of European Citizens and setting a standard of high quality for products entering the European Market, the European Commission requires that manufacturers selling machinery, sub-assemblies or safety components in the …. » more
• Updated on Dec 28, 2008

  Non European Medical Device Manufacturers

  The MDD 93/42/EEC Medical Device Directive, mandatory since June 14,1998 requires Non-European Medical Device Manufacturers to appoint a European Authorized Representative to sell their product in Europe .(MDD 93/42 Article 14) Obelis (O.E.A.R.C.) is the foremost Authorized Representative for your Medical Devices. Services for Class I Medical Device Products We provide …. » more