# Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices, Division 8.5

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

If the intended purpose of the device is not obvious to the user, the manufacturer must clearly state the intended purpose in the instructions for use and, if appropriate, on the label.

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Source: https://www.legislation.gov.uk/eudr/1998/79/annex/I/division/B/division/8/division/8.5 (the official version)
Page: https://openlegislation.uk/eu-directive-1998-79/annex-I/division-B/division-8/division-8.5
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.