# Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices, Division 2.4

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

Devices labelled either as ‘STERILE’ or as having a special microbiological state must have been processed by an appropriate, validated method.

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Source: https://www.legislation.gov.uk/eudr/1998/79/annex/I/division/B/division/2/division/2.4 (the official version)
Page: https://openlegislation.uk/eu-directive-1998-79/annex-I/division-B/division-2/division-2.4
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.