# 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 16

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

Confirmation that the device satisfies the requirements in respect of characteristics and performances, as referred to in I. ‘General requirements’, in normal conditions of use, and the evaluation of the side effects or undesirable effects must be based on clinical data established in accordance with Annex 7.

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Source: https://www.legislation.gov.uk/eudr/1990/385/annex/1/division/II/division/16 (the official version)
Page: https://openlegislation.uk/eu-directive-1990-385/annex-1/division-II/division-16
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.