# Council Directive 93/42/EEC of 14 June 1993 concerning medical devices, Division 2

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

The manufacturer must prepare the technical documentation described in Section 3. The manufacturer or his authorised representative must make this documentation, including the declaration of conformity, available to the national authorities for inspection purposes for a period ending at least five years after the last product has been manufactured. In the case of implantable devices the period shall be at least 15 years after the last product has been manufactured.

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Source: https://www.legislation.gov.uk/eudr/1993/42/annex/VII/division/2 (the official version)
Page: https://openlegislation.uk/eu-directive-1993-42/annex-VII/division-2
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.