# Council Directive 93/42/EEC of 14 June 1993 concerning medical devices, Division 4.2

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

The application must describe the design, manufacture and performances of the product in question. It must include the documents needed to assess whether the product conforms to the requirements of this Directive, as referred to in Section 3.2 (c).

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Source: https://www.legislation.gov.uk/eudr/1993/42/annex/II/division/4/division/4.2 (the official version)
Page: https://openlegislation.uk/eu-directive-1993-42/annex-II/division-4/division-4.2
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.