Medical devices may only be placed on the Union market if the requirements of the respective European regulation (MDR, IVDR) are met. These include, among other things, compliance with the general safety and performance requirements, the selection and implementation of an appropriate conformity assessment procedure, and the issuance of a corresponding declaration of conformity. By affixing the CE marking, the manufacturer declares that the respective medical device meets all applicable requirements.
The manufacturer is solely responsible for the medical device and its design and properties. He defines the medical intended purpose, in particular the type and manner of the principal effect and application of the medical device and classifies it in the respective medical device class. For medical devices of higher risk classes, a notified body must be involved.