# Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices, Division 2

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

The application for EC type-examination shall be lodged by the manufacturer or by his authorised representative with a notified body.
The application shall include:
the name and the address of the manufacturer and the name and address of the authorised 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 shall 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.

---
Source: https://www.legislation.gov.uk/eudr/1998/79/annex/V/division/2 (the official version)
Page: https://openlegislation.uk/eu-directive-1998-79/annex-V/division-2
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.