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

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

The application includes:
the name and address of the manufacturer and the name and address of the authorized representative if the application is lodged by the representative,
the documentation described in Section 3 needed to assess the conformity of the representative sample of the production in question, hereinafter referred to as the ‘type’, with the requirements of this Directive. The applicant must make a ‘type’ available to the notified body. The notified body may request other samples as necessary,
a written declaration that no application has been lodged with any other notified body for the same type.

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