# Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices, Division 4.2

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

The application must describe the design, manufacture and performances of the device in question. It must include the documents needed to assess whether the device 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/1998/79/annex/IV/division/4/division/4.2 (the official version)
Page: https://openlegislation.uk/eu-directive-1998-79/annex-IV/division-4/division-4.2
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.