# 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 1.3

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

The clinical evaluation and its outcome shall be documented. This documentation shall be included and/or fully referenced in the technical documentation of the device.

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Source: https://www.legislation.gov.uk/eudr/1990/385/annex/7/division/1/division/1.3 (the official version)
Page: https://openlegislation.uk/eu-directive-1990-385/annex-7/division-1/division-1.3
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.