In the European Union, the year 2017 brought about substantial changes in the regulation of medical device documentation. The new Medical Device Regulation (MDR), which replaces the previous EU Directive (MDD), requires much more detailed and stringent technical documentation than its predecessor. The conditions of compliance with the essential requirements have been tightened, and the Directive now covers a number of previously uncovered devices. In addition, post market clinical follow-up (PMCF) became of prominent importance and fell under detailed regulation. This renewed environment put a tremendous amount of challenges on device manufacturers and our aim is to reduce this burden, accordingly.
The following figure illustrates the process of transition to MDR & IVDR.