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 IV.
Article 3
Member States shall ensure that the services provided with the help of equipment meeting the requirements of this Directive are reimbursed on the same terms as the services provided with the help of equipment meeting the criteria required under the provisions in force within their territory- as regards the authorized applications and minimum requirements for the equipment.
Article 4
The following shall be adopted in accordance with the procedure laid down in Article 6: - any amendments to Annex I made necessary by the adaptation to technical progress of the harmonized standards by the relevant standards organization,
- any amendments to Annex I which are desirable because of adaptation to technical progress where the relevant standards organization has not made the corresponding amendments to the harmonized standard.
In the latter case, the amendments shall be notified to the competent standards organization.
Article 5
1. A Committee on the Adaptation to Technical Progress of the Directives for Removing Technical Barriers to Trade in Electro-medical Equipment (hereinafter called "the Committee") is hereby set up ; it shall consist of representatives of the Member States and shall be chaired by a Commission representative.
2. The Committee shall draw up its own rules of procedure.
Article 6
1. Where reference is made to the procedure laid down in this Article, the matter shall be referred to the Committee by its chairman, either on his own initiative or at the request of a representative of a Member State.
2. The Commission representative shall submit to the Committee a draft of the measures to be taken. The Committee shall give its opinion on that draft within a time limit set by the chairman having regard to the urgency of the matter. Opinions shall be delivered by a majority of 45 votes, the votes of the Member States being weighted as provided for in Article 148 (2) of the Treaty. The chairman shall not vote.
3. (a) Where the proposed measures are in accordance with the opinion of the Committee the Commission shall adopt them.
(b) Where the proposed measures are not in accordance with the opinion of the Committee or if no opinion is delivered, the Commission shall without delay submit to the Council a proposal on the measures to be taken. The Council shall act by a qualified majority.
(c) If, within three months of the proposal being submitted to it, the Council has not acted, the proposed measures shall be adopted by the Commission.
Article 7
1. If a Member State determines, on the basis of a substantiated justification, that one or more appliances, although complying with the requirements of this Directive, represent a hazard to safety, it may provisionally prohibit the sale, free movement or use of the appliance or appliances on its territory or make it subject to special conditions. It shall immediately inform the other Member States and the Commission thereof, stating the grounds for its decision.
2. The Commission shall, within six weeks, consult the Member States concerned, following which it shall deliver its opinion without delay and take the appropriate steps.
3. If the Commission is of the opinion that technical adaptations to the Directive are necessary, such adaptations shall be adopted by either the Commission or the Council in accordance with the procedure laid down in Article 6. In that case, the Member State which has adopted the safeguard measures may maintain them until the entry into force of the adaptations.
Article 8
1. Member States shall take all appropriate measures to ensure that the marks and declaration of conformity referred to in Article 2 are issued by the manufacturer or the importer only under the conditions laid down in the Directive.
2. Member States shall make all necessary arrangements to ensure adequate surveillance of the manufacture of the equipment.
Article 9
Member States shall take all appropriate measures to prevent the use on equipment of marks or markings which might be confused with the EEC mark described in Annex III.
Article 10
1. Member States shall bring into force the measures necessary to comply with this Directive within 24 months of its notification and shall forthwith inform the Commission thereof (1).
2. Member States shall communicate to the Commission the texts of the provisions of national law which they adopt in the field governed by this Directive.
Article 11
This Directive is addressed to the Member States.
Done at Brussels, 17 September 1984.