# Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices, Division 2.3

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

Devices labelled either as ‘STERILE’ or as having a special microbiological state must be designed, manufactured and packed in an appropriate pack, according to procedures suitable for ensuring that they remain in the appropriate microbiological state indicated on the label when placed on the market, under the storage and transport conditions specified by the manufacturer, until the protective packaging is damaged or opened.

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Source: https://www.legislation.gov.uk/eudr/1998/79/annex/I/division/B/division/2/division/2.3 (the official version)
Page: https://openlegislation.uk/eu-directive-1998-79/annex-I/division-B/division-2/division-2.3
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.