# 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 6.1

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

For at least 15 years from the last date of manufacture of the product, the manufacturer or his authorised representative shall keep available for the national authorities:
the declaration of conformity,
the documentation referred to in the second indent of Section 3.1, and in particular the documentation, data and records referred to in the second paragraph of Section 3.2,
the amendments referred to in Section 3.4,
the documentation referred to in Section 4.2,
the decisions and reports of the notified body referred to in Sections 3.4, 4.3, 5.3 and 5.4.

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Source: https://www.legislation.gov.uk/eudr/1990/385/annex/2/division/6/division/6.1 (the official version)
Page: https://openlegislation.uk/eu-directive-1990-385/annex-2/division-6/division-6.1
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.