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 re-designation of notified bodies (NBs; and therefore, a possible decrease in the number of designated NBs), the tightening of requirements specified in MDR and IVDR, and the short-deadlines indicated by the figure above are all call for preparation as soon as possible. If you have any questions about the new regulation or the transition, find our contact details on the website. We are happy to help you!

For our interested visitors, we have compiled some case studies and/or summaries that represent the challenges posed by MDR/IVDR through fictitious examples of various risk category devices.

Case Studies