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Council Directive of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices (90/385/EEC)

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Changes over time for: Article 7

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Article 7U.K.+E.U.

1.Where a Member State finds that the devices referred to in Article 1 (2) (c) and (d), correctly put into service and used in accordance with their intended purpose, may compromise the health and/or safety of patients, users or, where applicable, other persons, it shall take all appropriate measures to withdraw such devices from the market or prohibit or restrict their being placed on the market or their being put into service.

The Member State shall immediately inform the Commission of any such measure, indicating the reasons for its decision and, in particular, whether non-compliance with this Directive is due to:

(a)

failure to meet the essential requirements referred to in Article 3, where the device does not meet in full or in part the standards referred to in Article 5;

(b)

incorrect application of those standards;

(c)

shortcomings in the standards themselves.

2.The Commission shall enter into consultation with the parties concerned as soon as possible. Where, after such consultation, the Commission finds that:

  • the measures are justified, it shall immediately so inform the Member State which took the initiative and the other Member States; where the decision referred to in paragraph 1 is attributed to shortcomings in the standards, the Commission shall, after consulting the parties concerned, bring the matter before the Committee referred to in Article 6 (1) within two months if the Member State which has taken the decision intends to maintain it and shall initiate the procedures referred to in Article 6 (1),

  • the measures are unjustified, it shall immediately so inform the Member State which took the initiative and the manufacturer or his authorized representative established within the Community.

3.Where a device which does not comply bears the [F1CE marking], the competent Member State shall take appropriate action against whomsoever has affixed the mark and shall inform the Commission and the other Member States thereof.

4.The Commission shall ensure that the Member States are kept informed of the progress and outcome of this procedure.

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