​Notified bodies are designated by the authorities to conduct conformity assessments, i.e. to assess whether a medical device complies with the regulatory requirements.

Following medical device has to be assessed by a notified body before CE-marking can be done:

  • Class Is device (sterile)
  • Class Im device (with measuring function )
  • Class IIa device
  • Class IIb device
  • Class III device

If the documentation for the medical device from the manufacturer conform with the legal requirements the notified body issues a certificate. This certificate is needed by the manufacturer to CE-mark their medical device.

Sist faglig oppdatert: 1. september 2016

skriv ut del på facebook del på twitter