# 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 inspection staff must have:
sound vocational training covering all the assessment and verification operations for which the body has been designated,
satisfactory knowledge of the rules on the inspections which they carry out and adequate experience of such inspections,
the ability required to draw up the certificates, records and reports to demonstrate that the inspections have been carried out.

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