# 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.

The manufacturer or his authorized representative established within the Community shall take all measures necessary in order that the manufacturing process ensures conformity of the products to the type as described in the EC type-examination certification and to the requirements of this Directive that apply to them. The manufacturer or his authorized representative established within the Community shall affix the CE marking to each product and draw up a written declaration of conformity.

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Source: https://www.legislation.gov.uk/eudr/1990/385/annex/4/division/2 (the official version)
Page: https://openlegislation.uk/eu-directive-1990-385/annex-4/division-2
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.