# Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices, Division 4

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

The manufacturer shall take necessary measures to ensure that the manufacturing process follows the principles of quality assurance as appropriate for the products manufactured.
The system shall address:
the organisational structure and responsibilities,
the manufacturing processes and systematic quality control of production,
the means to monitor the performance of the quality system.

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Source: https://www.legislation.gov.uk/eudr/1998/79/annex/III/division/4 (the official version)
Page: https://openlegislation.uk/eu-directive-1998-79/annex-III/division-4
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.