# 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 6.2

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

A random sample shall be taken from each batch. Products in a sample shall be individually examined and appropriate tests, as set out in the standard(s) referred to in Article 5, or equivalent tests shall be carried out to verify their conformity to the type as described in the EC type-examination certificate and thereby determine whether a batch is to be accepted or rejected.

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Source: https://www.legislation.gov.uk/eudr/1990/385/annex/4/division/6/division/6.2 (the official version)
Page: https://openlegislation.uk/eu-directive-1990-385/annex-4/division-6/division-6.2
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.