Article 14

F1Any decision taken pursuant to this Directive

1. (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

2. (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.

F2In 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.