# Council Directive 93/42/EEC of 14 June 1993 concerning medical devices, Division 6.1

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, keep at the disposal of the national authorities:
the declaration of conformity,
the documentation referred to in the fourth indent of Section 3.1 and in particular the documentation, data and records referred to in the second paragraph of Section 3.2,
the changes referred to in Section 3.4,
the documentation referred to in Section 4.2, and
the decisions and reports from the notified body as referred to in Sections 3.3, 4.3, 4.4, 5.3 and 5.4.

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Source: https://www.legislation.gov.uk/eudr/1993/42/annex/II/division/6/division/6.1 (the official version)
Page: https://openlegislation.uk/eu-directive-1993-42/annex-II/division-6/division-6.1
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.