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European Directives Covered by Obelis

Obelis offers services for the following European Directives.

 

CE Marking 93/68/EEC

CE Marking 93/68/EEC

CE Marking Directive 93/68/EEC of July 22, 1993 amending Directives 87/404/EEC (simple pressure vessels), 88/378/EEC (safety of toys), 89/106/EEC (construction products), 89/336/EEC (electromagnetic compatibility), 89/392/EEC (machinery),

Read more: CE Marking 93/68/EEC


 

MDD 93/42/EEC - Medical Device Directive

MDD 93/42/EEC - Medical Device Directive

MDD 93/42/EEC (Medical Device Directive) has been in place since June 14, 1998. It was amended on September 5, 2007. The consolidated directive will become mandatory on March 21, 2010. The directive establishes essential requirements and harmonized standards for the manufacture, design, and packaging of medical devices. A medical device is defined as any instrument, apparatus, appliance, software, material or other article. This includes if this device is used alone or in combination with software necessary for its proper application intended by the manufacturer to be used for human beings in the purpose of:

  • diagnosis, prevention, monitoring, treatment or alleviation of disease
  • diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap
  • investigation, replacement or modification of the anatomy or of a physiological process control of conception and which does achieve its principal intended action by pharmacological process, immunological or metabolic means but may be assisted in its function by such means.

Read more: MDD 93/42/EEC - Medical Device Directive


The Directive


The Directive


The Directive


 

AIMDD 90/385/EEC - Active Implantable Medical Devices Directive

AIMDD 90/385/EEC - Active Implantable Medical Devices Directive

AIMDD (Active Implantable Medical Device Directive) 90/385/EEC has been in place since June 20, 1990. This directive applies to devices according to Article 2.C AIMDD, which defines an active implantable medical device as:

Read more: AIMDD 90/385/EEC - Active Implantable Medical Devices Directive


The Directive


 

IVDD 98/79/EC - In-Vitro Diagnostic Device Directive

IVDD 98/79/EC - In-Vitro Diagnostic Device Directive

IVD 98/79/EC (In-Vitro Diagnostic Medical Device Directive) was published on October 7, 1998. It is separate from the Medical Device Directive with its own separate set of requirements for manufacturers wishing to place medical devices in the European Economic Area. This directive does not specifically list out the devices that fall under it. Rather, the responsibility is placed on the manufacturer to determine what directives apply to their device. The directive sets out device requirements, requirements for manufactures placing the device on the market, and also demands on safety and quality of the devices.

Read more: IVDD 98/79/EC - In-Vitro Diagnostic Device Directive


The Directive


The Directive


 

Cosmetics Directive 76/768/EEC

Cosmetics Directive 76/768/EEC

The Cosmetics Directive 76/768/EEC was published on July 27, 1976. It allows cosmetic products in the European Economic Area to circulate freely and ensures their safety for use. A cosmetic product is any substance intended to make contact with external parts of the human body, or inside the mouth, with the intention of cleaning or perfuming them, changing their appearance, correcting odors, protecting them or maintaining their good condition. These products must not be harmful to health when used under normal conditions.

Read more: Cosmetics Directive 76/768/EEC


The Directive

The NEW Directive


 

EMC Directive 2004/108/EC - Electromagnetic Compatibility Directive

EMC Directive 2004/108/EC - Electromagnetic Compatibility Directive

EMC Directive 2004/108/EC (Electromagnetic Compatibility Directive) of the European Parliament and of the Council was published on December 31, 2004 in the Official Journal of the European Union, L 390/24, and replaced Directive 89/336/EEC on July 20, 2007.

Read more: EMC Directive 2004/108/EC - Electromagnetic Compatibility Directive


The Directive


 

LVD 2006/95/EC - Low Voltage Directive

LVD 2006/95/EC - Low Voltage Directive

LVD 2006/95/EC ( Low Voltage Directive) of the European Parliament and of the Council of December 12, 2006 on the harmonization of the laws of Member States relating to electrical equipment designed for use within certain voltage limits (codified version) was published in the OJEU L 374 on December 27, 2006, p. 10-19. It entered into force on the 20th day following that of its publication, i.e. on January 16, 2007. The old directive 73/23/EEC was repealed on the same date.

Read more: LVD 2006/95/EC - Low Voltage Directive


The Directive


 

R&TTE 1999/5/EC - Radio and Telecommunications Terminal Equipment Directive

R&TTE 1999/5/EC - Radio and Telecommunications Terminal Equipment Directive

The R&TTE Directive 1999/5/EC (Radio and Telecommunications Terminal Equipment Directive) was published on March 9, 1999. It covers all apparatuses using the radio frequency spectrum and all equipment associated with public telecommunications networks, for example mobile phones and wireless devices such as Bluetooth devices, wireless network routers and car door openers.

Read more: R&TTE 1999/5/EC - Radio and Telecommunications Terminal Equipment Directive


The Directive


 

GPSD 2001/95/EC - General Product Safety Directive

GPSD 2001/95/EC - General Product Safety Directive

The GPSD 2001/95/EC (General Product Safety Directive) was published on January 15, 2004. In order to place products in the European Economic Area, distributors and manufacturers must comply with this directive. The aims of the directive are to protect consumers’ health and safety and to ensure the EEA functions properly in relation to this directive.

Read more: GPSD 2001/95/EC - General Product Safety Directive


The Directive


 

PPE 89/686/EEC - Personal Protective Equipment Directive

PPE 89/686/EEC - Personal Protective Equipment Directive

PPE Directive 89/686/EEC (Personal Protective Equipment Directive) was published on June 1995 and covers Personal Protective Equipment (PPE). It is defined as “any device to be worn or held by an individual for protection against one or more health and safety hazards”.

89/686/EEC concerning Personal Protective Equipment (PPE) has 17 Articles and 6 Annexes. Originally published in 1989, the PPE directive only has three 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 European Commissions continuing efforts to create free movement of goods in the European Economic Area through the use
of harmonized standards.

Read more: PPE 89/686/EEC - Personal Protective Equipment Directive


The Directive


 

TSD 2009/48/EC - Toy Safety Directive

TSD 2009/48/EC - Toy Safety Directive

The European Parliament and Council Directive 2009/48/EC on the safety of toys (“TSD” - Toy Safety Directive) was published on 30 June 2009 and entered into force on 20 July 2009 aimed to entirely repeal the TSD 88/378/EEC (Toy Safety Directive), Council Directive 88/378/EEC of March 3, 1988 which was published on January 1, 1990.

Read more: TSD 2009/48/EC - Toy Safety Directive


The Directive

The NEW Directive


 

PED 97/23/EC - Pressure Equipment Directive

PED 97/23/EC - Pressure Equipment Directive

PED 97/23/EC (Pressure Equipment Directive) adopted by the European Parliament and the European Council on May 29, 1997 was published on May 29, 2002. Previously, manufacturers of pressure equipment could decide if the product would meet the Pressure Equipment Directive requirements or continue applying the existing national legislation. On May 29, 2002, the PED was made obligatory throughout the European Economic Area.

Read more: PED 97/23/EC - Pressure Equipment Directive


The Directive


 

MVD 2007/46/EC - Motor Vehicle Directive

MVD 2007/46/EC - Motor Vehicle Directive

The European Union (EU) is revising the framework for the approval of motor vehicles with a new Directive (2007/46/EC), which repeals and replaces Directive 70/156/EEC in order to have a clearer, more coherent text based on the principle of proportionality. The new Directive retains (in revised form) the majority of the provisions of the former Directive but also introduces some entirely new concepts and requirements.

Read more: MVD 2007/46/EC - Motor Vehicle Directive

The NEW Directive


The Directive


 

ATEX 94/9/EC Directive

ATEX 94/9/EC Directive

The Equipment and Protective systems intended for use in Potentially Explosive Atmospheres (ATEX) Directive 94/9/EC of 23 March 1994, provides the essential health and safety requirements – leaving to standards developed by European standardization organizations their technical expression - and the relevant conformity assessment procedures before placing such equipment on the European market.

Read more: ATEX 94/9/EC Directive


The Directive


 

MSD 2006/42/EC - Machinery Safety Directive

MSD 2006/42/EC - Machinery Safety Directive

The revised Machinery Directive 2006/42/EC does not introduce any radical changes compared with the old Machinery Directive 98/37/EC but aims at consolidating the achievements of the Machinery Directive in terms of free circulation and safety of machinery while improving its application. Thus, the provisions of the new Directive became applicable on 29th December 2009.

Read more: MSD 2006/42/EC - Machinery Safety Directive


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