# Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices, Division 3.1

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

The manufacturer must lodge an application for assessment of his quality system with a notified body.
The application must include:
the name and address of the manufacturer and any additional manufacturing site covered by the quality system,
adequate information on the device or device category covered by the procedure,
a written declaration that no such application has been lodged with any other notified body for the same device-related quality system,
the documentation on the quality system,
an undertaking by the manufacturer to fulfil the obligations imposed by the quality system approved,
an undertaking by the manufacturer to keep the approved quality system adequate and efficacious,
an undertaking by the manufacturer to institute and keep up to date a systematic procedure to review experience gained from devices in the post-production phase and to implement appropriate means to apply any necessary corrective action and notification as referred to in Annex III, section 5.

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Source: https://www.legislation.gov.uk/eudr/1998/79/annex/IV/division/3/division/3.1 (the official version)
Page: https://openlegislation.uk/eu-directive-1998-79/annex-IV/division-3/division-3.1
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.