Directive 1984/539 - Approximation of the laws of the Member States relating to electro-medical equipment used in human or veterinary medicine - Main contents

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Council Directive 84/539/EEC of 17 September 1984 on the approximation of the laws of the Member States relating to electro-medical equipment used in human or veterinary medicine

Official Journal L 300 , 19/11/1984 P. 0179 - 0187

Finnish special edition: Chapter 13 Volume 14 P. 0131

Spanish special edition: Chapter 13 Volume 18 P. 0133

Swedish special edition: Chapter 13 Volume 14 P. 0131

Portuguese special edition Chapter 13 Volume 18 P. 0133

COUNCIL DIRECTIVE of 17 September 1984 on the approximation of the laws of the Member States relating to electro-medical equipment used in human or veterinary medicine (84/539/EEC)

THE COUNCIL OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European Economic Community, and in particular Article 100 thereof,

Having regard to the proposal from the Commission (1),

Having regard to the opinion of the European Parliament (2),

Having regard to the opinion of the Economic and Social Committee (3),

Whereas, in each Member State, electro-medical equipment used in human or veterinary medicine must meet a high and clearly-defined degree of safety both for the users of such equipment and for those receiving treatment by means of the equipment;

Whereas several Member States have sought to ensure that degree of safety by mandatory specifications relating both to the technical safety regulations and the inspection procedures ; whereas those specifications differ from one Member State to another;

Whereas these obstacles to the establishment and operation of the common market can be reduced or even eliminated if the same specifications are adopted by all the Member States, either in addition to or in place of their present legislation;

Whereas it is advisable in the first instance to harmonize at Community level one section of the equipment in question ; whereas the most adequate form of harmonization is by reference to the standards drawn up by the European Committee for Electrotechnical Standardization (Cenelec);

Whereas, in order to ensure that the equipment complies with the harmonized standards, the manufacturer acknowledges his responsibility by a mark or declaration of conformity;

Whereas technical progress requires prompt adaptation of the technical specifications laid down by the Directives with respect to electro-medical equipment ; whereas, in order to facilitate the implementation of the measures required, provision should be made for a procedure establishing dose cooperation between the Member States and the Commission within the Committee on the Adaptation to Technical Progress of the Directives for Removing Technical Barriers to Trade in Electro-medical Equipment;

Whereas electro-medical equipment, although conforming to the requirements of this Directive, might endanger public safety and health ; whereas a procedure should therefore be laid down to obviate this risk,

HAS ADOPTED THIS DIRECTIVE:

Article 1

This Directive shall apply to the electro-medical equipment listed in Annex II (hereinafter called "equipment") which is intended, by its nature, for use in human or veterinary medicine.

Article 2

• 1. 

  Member States may not, on grounds of safety relating to its manufacture, refuse, prohibit or restrict the sale, free movement or use for its intended purpose of the equipment referred to in Article 1 of this Directive where it conforms with the requirements of this Directive.

Annex I contains the technical requirements to which the equipment must conform. (1) OJ No C 33, 12.2.1975, p. 5. (2) OJ No C 76, 14.3.1975, p. 37. (3) OJ No C 233, 17.11.1975, p. 39.

• 2. 

  The conformity of equipment to the requirements of this Directive shall be attested by the manufacturer or by the importer, under the latter's responsibility, by the affixing of a mark which conforms to the specimen shown in Annex III or by a declaration which conforms to the specimen shown in Annex...

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