# 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 5

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

The notified body shall carry out the appropriate examinations and tests in order to check the conformity of the product to the requirements of this Directive by examination and testing of products on a statistical basis, as specified in section 6. The manufacturer must authorize the notified body to evaluate the efficiency of the measures taken pursuant to section 3, by audit where appropriate.

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Source: https://www.legislation.gov.uk/eudr/1990/385/annex/4/division/5 (the official version)
Page: https://openlegislation.uk/eu-directive-1990-385/annex-4/division-5
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.