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)

6. The applicant shall inform the notified body which issued the EC type-examination certificate of any modification made to the approved product. U.K.

Modifications to the approved product must receive further approval from the notified body which issued the EC type-examination certificate where such modifications may affect conformity with the essential requirements or with the conditions of use specified for the product. This new approval shall be issued, where appropriate, in the form of a supplement to the initial EC type-examination certificate.