Conformity assessment is the evaluation of whether a medical device complies with the regulatory requirements for medical devices.
Depending on the risk class of the medical device, the conformity assessment shall be performed either by the manufacturer alone or with the assistance of a notified body.
A notified body is an independent third party that assesses whether the medical device complies with the regulatory requirements.
Read more about conformity assessment without a notified body
The conformity assessment shall result in a declaration of conformity in which the manufacturer confirms in writing that the medical device complies with the relevant regulatory requirements. CE marking is affixed to the medical device as a symbol of this.