# Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices, Division 3.1

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

The manufacturer must lodge an application for assessment of his quality system with a notified body.
The application must include:
the technical documentation on the types approved and a copy of the EC type-examination certificates.

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Source: https://www.legislation.gov.uk/eudr/1998/79/annex/VII/division/3/division/3.1 (the official version)
Page: https://openlegislation.uk/eu-directive-1998-79/annex-VII/division-3/division-3.1
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.