# Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices, Division 3

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

The documentation must allow an understanding of the design, the manufacture and the performances of the device. The documentation shall contain the following items in particular:
a general description of the type, including any variants planned,
all documentation referred to in Annex III, section 3, indents 3 to 13,
in the case of devices for self testing, the information referred to in Annex III, section 6.1.

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Source: https://www.legislation.gov.uk/eudr/1998/79/annex/V/division/3 (the official version)
Page: https://openlegislation.uk/eu-directive-1998-79/annex-V/division-3
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.