# Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices, Division 3.4

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

The manufacturer shall inform the notified body which approved the quality system of any plan for substantial changes to the quality system.
The notified body must assess the changes proposed and verify whether after these changes the quality system still meets the requirements referred to in section 3.2. It must notify the manufacturer of its decision. This decision must contain the conclusions of the inspection and a reasoned assessment.

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Source: https://www.legislation.gov.uk/eudr/1998/79/annex/VII/division/3/division/3.4 (the official version)
Page: https://openlegislation.uk/eu-directive-1998-79/annex-VII/division-3/division-3.4
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.