# 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 4.1

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

In addition to the obligations incumbent on him under section 3, the manufacturer shall make an application for examination of the design dossier relating to the product which he plans to manufacture and which falls into the category referred to in 3.1.

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Source: https://www.legislation.gov.uk/eudr/1990/385/annex/2/division/4/division/4.1 (the official version)
Page: https://openlegislation.uk/eu-directive-1990-385/annex-2/division-4/division-4.1
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.