# Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices, Division 2.2

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

To the extent that for certain aspects the final testing according to section 6.3 is not appropriate, adequate process testing, monitoring and control methods shall be established by the manufacturer with the approval of the notified body. The provisions of Annex IV, section 5, shall apply accordingly in relation to the abovementioned approved procedures.

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Source: https://www.legislation.gov.uk/eudr/1998/79/annex/VI/division/2.2 (the official version)
Page: https://openlegislation.uk/eu-directive-1998-79/annex-VI/division-2.2
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.