# 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 5

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

For custom-made devices, the manufacturer must undertake to review and to document experience gained in the post-production phase, including the provisions referred to in Annex 7, and to implement appropriate means to apply any necessary corrective action. This undertaking must include an obligation for the manufacturer to notify the competent authorities of the following incidents immediately on learning of them and the relevant corrective actions:
(i) any malfunction or deterioration in the characteristics and/or performance of a device, as well as any inadequacy in the labelling or the instructions for use which might lead to or might have led to the death of a patient or user or to a serious deterioration in his state of health;
(ii) any technical or medical reason connected with the characteristics or performance of a device for the reasons referred to in point (i) leading to systematic recall of devices of the same type by the manufacturer.

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Source: https://www.legislation.gov.uk/eudr/1990/385/annex/6/division/5 (the official version)
Page: https://openlegislation.uk/eu-directive-1990-385/annex-6/division-5
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.