# Council Directive 93/42/EEC of 14 June 1993 concerning medical devices, Division 5.1

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

The manufacturer or his authorised representative must, for a period ending at least five years, and in the case of implantable devices at least 15 years, after the last product has been manufactured, make available to the national authorities:
the declaration of conformity,
the documentation referred to in the seventh indent of Section 3.1,
the changes referred to in Section 3.4,
the decisions and reports from the notified body as referred to in the final indent of Section 3.4 and in Sections 4.3 and 4.4,
where appropriate, the certificate of conformity referred to in Annex III.

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Source: https://www.legislation.gov.uk/eudr/1993/42/annex/VI/division/5/division/5.1 (the official version)
Page: https://openlegislation.uk/eu-directive-1993-42/annex-VI/division-5/division-5.1
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.