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)

[F1 Article 10c U.K.

Where a Member State considers in relation to a given product or group of products that, in order to ensure protection of health and safety and/or to ensure that public health requirements are observed, such products should be withdrawn from the market, or their placing on the market and putting into service should be prohibited, restricted or subjected to particular requirements, it may take any necessary and justified transitional measures.

The Member State shall then inform the Commission and all the other Member States of the transitional measures, giving the reasons for its decision.

The Commission shall, whenever possible, consult the interested Parties and the Member States. The Commission shall adopt its opinion, indicating whether the national measures are justified or not. The Commission shall inform all the Member States and the consulted interested Parties.

When appropriate, the necessary measures designed to amend non-essential elements of this Directive, by supplementing it, relating to withdrawal from the market, prohibition of placing on the market and putting into service of a certain product or group of products or to restrictions or introduction of particular requirements therefor, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 6(4). On imperative grounds of urgency, the Commission may use the urgency procedure referred to in Article 6(5).]

Textual Amendments

F1 Inserted by Directive 2007/47/EC of the European Parliament and of the Council of 5 September 2007 amending Council Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices, Council Directive 93/42/EEC concerning medical devices and Directive 98/8/EC concerning the placing of biocidal products on the market (Text with EEA relevance).