# 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 1

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

The manufacturer or his authorized representative established within the Community shall draw up for custom-made devices or for devices intended for clinical investigations the statement comprising the elements stipulated in section 2.

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Source: https://www.legislation.gov.uk/eudr/1990/385/annex/6/division/1 (the official version)
Page: https://openlegislation.uk/eu-directive-1990-385/annex-6/division-1
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.