# Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices, Division 5.3

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

The notified body must periodically carry out appropriate inspections and assessments to make sure that the manufacturer applies the approved quality system and must supply the manufacturer with an assessment report.

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Source: https://www.legislation.gov.uk/eudr/1998/79/annex/IV/division/5/division/5.3 (the official version)
Page: https://openlegislation.uk/eu-directive-1998-79/annex-IV/division-5/division-5.3
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.