# 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.

Where a device incorporates biological substances, the risks of infection must be reduced as far as possible by selecting appropriate donors and appropriate substances and by using appropriate, validated inactivation, conservation, test and control procedures.

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Source: https://www.legislation.gov.uk/eudr/1998/79/annex/I/division/B/division/2/division/2.2 (the official version)
Page: https://openlegislation.uk/eu-directive-1998-79/annex-I/division-B/division-2/division-2.2
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.