# Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices, Division 3.3

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

The notified body must audit the quality system to determine whether it meets the requirements referred to in section 3.2. It must presume that quality systems which implement the relevant harmonised standards conform to the requirements.
The assessment team must have experience of assessments of the technology concerned. The assessment procedure must include an inspection on the manufacturer's premises and, in duly substantiated cases, on the premises of the manufacturer's suppliers and/or subcontractors to inspect the manufacturing processes.
The decision shall be notified to the manufacturer. It must contain the conclusions of the inspection and a reasoned assessment.

---
Source: https://www.legislation.gov.uk/eudr/1998/79/annex/IV/division/3/division/3.3 (the official version)
Page: https://openlegislation.uk/eu-directive-1998-79/annex-IV/division-3/division-3.3
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.