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.