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)

Article 14 U.K.

[F1 Any decision taken pursuant to this Directive

(a)

to refuse or restrict the placing on the market or the putting into service of a device or the carrying out of clinical investigations;

or

(b)

to withdraw devices from the market

shall state the exact grounds on which it is based. Such a decision shall be notified without delay to the party concerned, who shall at the same time be informed of the remedies available to him under the laws in force in the Member State in question and of the time limits to which such remedies are subject.]

[F2 In the event of a decision as referred to in the previous paragraph the manufacturer, or his authorized representative [F3 established in the Community] , shall have an opportunity to put forward his viewpoint in advance, unless such consultation is not possible because of the urgency of the measures to be taken.]

Textual Amendments

F1 Substituted 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).

F2 Inserted by Council Directive 93/42/EEC of 14 June 1993 concerning medical devices.

F3 Deleted 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).