The new conformity assessment procedures of the MDR
The European Parliament and the Council of Ministers will soon pass the new Medical Device Regulation (MDR). As experts do not expect the future requirements governing the approval of medical devices on the EU market to undergo further major amendments, the extent to which the conformity assessment procedures will change compared to those of the former Medical Device Directive (MDD) is now foreseeable. In the MDR, the conformity assessment procedures are described in other Annexes than in the MDD. The Annexes also have been reorganized and renumbered. The diagram below illustrates conformity assessment procedures by risk class.
(Please note that each conformity assessment procedure may include further detailed regulations that cannot be illustrated in this summary diagram.)