# Council Directive of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices (90/385/EEC), Division 2

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

The application for EC type-examination shall be made by the manufacturer, or by his authorized representative established in the Community, to a notified body.
The application shall include:
the name and address of the manufacturer and the name and address of the authorized representative if the application is made by the latter,
a written declaration specifying that an application has not been made to any other notified body,
the documentation described in section 3 needed to allow an evaluation to be made of the conformity of a representative sample of the production in question, hereinafter referred to as ‘type’, with the requirements of this Directive.
The applicant shall make a ‘type’ available to the notified body. The notified body may request other samples as necessary.

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Source: https://www.legislation.gov.uk/eudr/1990/385/annex/3/division/2 (the official version)
Page: https://openlegislation.uk/eu-directive-1990-385/annex-3/division-2
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.