​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.