# Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices, Division 5

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

The devices must be designed, manufactured and packed in such a way that their characteristics and performances during their intended use will not be adversely affected under storage and transport conditions (temperature, humidity, etc.) taking account of the instructions and information provided by the manufacturer.

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Source: https://www.legislation.gov.uk/eudr/1998/79/annex/I/division/A/division/5 (the official version)
Page: https://openlegislation.uk/eu-directive-1998-79/annex-I/division-A/division-5
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.