# 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 3

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

The manufacturer shall, before the start of manufacture, prepare documents defining the manufacturing processes, in particular as regards sterilization, together with all the routine, pre-established provisions to be implemented to ensure uniformity of production and conformity of the products with the type as described in the EC type-examination certificate as well as with the relevant requirements of this Directive.

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Source: https://www.legislation.gov.uk/eudr/1990/385/annex/4/division/3 (the official version)
Page: https://openlegislation.uk/eu-directive-1990-385/annex-4/division-3
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.