# Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices, Division 6

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

The manufacturer shall inform the notified body without delay if it has obtained information about changes to the pathogen and markers of infections to be tested, in particular as a consequence of biological complexity and variability. In this connection, the manufacturer shall inform the notified body whether any such change is likely to affect the performance of the in vitro device concerned.

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Source: https://www.legislation.gov.uk/eudr/1998/79/annex/V/division/6 (the official version)
Page: https://openlegislation.uk/eu-directive-1998-79/annex-V/division-6
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.