Directive 98/79/EC of the European Parliament and of the CouncilShow full title

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

4.The inspection staff must have:U.K.

  • 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.