Council Directive 93/42/EECShow full title

Council Directive 93/42/EEC of 14 June 1993 concerning medical devices

4.The notified body 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.