# Council Directive 93/42/EEC of 14 June 1993 concerning medical devices, Division 7: Administrative provisions

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 Section 2,
the certificates referred to in Sections 5.2 and 6.4,
where appropriate, the type-examination certificate referred to in Annex III.

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Source: https://www.legislation.gov.uk/eudr/1993/42/annex/IV/division/7 (the official version)
Page: https://openlegislation.uk/eu-directive-1993-42/annex-IV/division-7
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.