# 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), Division 2

Extent: E+W+S+N.I.

This declaration of conformity is the procedural element whereby the manufacturer who satisfies the obligations of section 1 guarantees and declares that the products concerned conform to the type described in the EC type-examination certificate and meet the provisions of the Directive which apply to them.
The manufacturer or his authorized representative established within the Community shall affix the CE marking in accordance with Article 12 and draw up a written declaration of conformity. This declaration shall cover one or more devices manufactured, clearly identified by means of product name, product code or other unambiguous reference and must be kept by the manufacturer . The CE marking shall be accompanied by the identification number of the notified body responsible.

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Source: https://www.legislation.gov.uk/eudr/1990/385/annex/5/division/2 (the official version)
Page: https://openlegislation.uk/eu-directive-1990-385/annex-5/division-2
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.