# 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 declaration of conformity is the part of the procedure whereby the manufacturer who fulfils the obligations imposed by section 1 ensures and declares that the products concerned conform to the type described in the EC type-examination certificate and meet the provisions of this Directive which apply to them.
The manufacturer must affix the CE marking in accordance with Article 16 and draw up a declaration of conformity covering the devices concerned.

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