Article 19 Decision in respect of refusal or restriction

United Kingdom

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;

(b)

to withdraw devices from the market,

shall state the exact grounds on which it is based. Such decisions 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 national law in force in the Member State in question and of the time limits to which such remedies are subject.

In the event of a decision as referred to in paragraph 1, the manufacturer, or his authorized representativeF1 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 measure to be taken.

Annotations

Textual amendments

F1: 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).