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)

[F1Article 13 U.K.

Without prejudice to Article 7

(a)

where a Member State establishes that the CE marking has been affixed unduly or is missing in violation of this Directive, the manufacturer or his authorised representative established within the Community shall be obliged to end the infringement under conditions imposed by the Member State;

(b)

where non-compliance continues, the Member State must take all appropriate measures to restrict or prohibit the placing on the market of the device in question or to ensure that it is withdrawn from the market in accordance with the procedures laid down in Article 7.

Those provisions shall also apply where the CE marking has been affixed in accordance with the procedures in this Directive, but inappropriately, on products that are not covered by this Directive.]