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European Directives Covered by Obelis

Obelis offers services for the following European Directives.

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),

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.

The 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:

The 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.

The Directive

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.

The Directive

The NEW Directive

MSD 98/37/EC - Machinery Safety Directive

MSD 98/37/EC (Machinery Safety Directive) of the European Parliament and of the Council of June 22, 1998 was published on January 1, 1993. It has been amended according to the 2006/42/EC. The directive is in approximation of the laws of the Member States relating to machinery. It provides the harmonization of the essential health and safety requirements for machinery in the European Economic Area.

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.

The 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.

The 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.

The 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.

The 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.

The Directive

CPD 89/106/EEC - Construction Products Directive

CPD 89/106/EEC (Construction Products Directive) was published on December 21, 1988 by the European Council on the approximation of laws, regulations and administrative provisions of the Member States. It was then amended by the Council Directive 93/68/EEC on July 22, 1993 and Regulation (EC) No 1882/2003 on September 29, 2003. The directive harmonizes all construction products subject to regulatory controls for CE marking purposes.

The 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.

The Directive

TSD 88/378/EEC - Toy Safety Directive

TSD 88/378/EEC (Toy Safety Directive), Council Directive 88/378/EEC of March 3, 1988 was published on January 1, 1990 on the approximation of the laws of the Member States concerning the safety of toys.

The safety of toys is harmonized at the European level so that the essential requirements can be met at the manufacturing stage. The standards laid down by the European standardization bodies provide evidence of compliance with the essential requirements. Toys that meet these requirements bear the CE marking.

The Directive

The NEW Directive