CMDs shall be accompanied by an classification statement. This statement shall be made available to the particular patient or user identified by a name, an acronym or a numerical code.
A conformity assessment procedure covering QMS certification by a notified body is applicable to Class III implantable CMDs. The registration of QMS-certificates issued for Class III implantable CMD shall be entered into EUDAMED.
CMD manufacturers are exempt from device UDI registration, assignment and labeling requirements. As such, and although they must appoint a person responsible for regulatory compliance (PRRC) they are not required to register these persons in EUDAMED.