# 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

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

The manufacturer shall undertake to institute and keep updated a post-marketing surveillance system including the provisions referred to in Annex 7 . This undertaking shall include the obligation on the part of the manufacturer to notify the competent authorities of the following events immediately on learning of them:
(i) any change in the characteristics or performances and any inaccuracies in the instruction leaflet for a device which might lead to or have led to the death of a patient or deterioration in his state of health;
(ii) any technical or medical reason resulting in the withdrawal of a device from the market by a manufacturer.

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