ARTICLE SUMMARY:
The new European Medical Device Regulation has been effective since May 26, 2021, but now comes the hard part: figuring out what it means and how it works. Senior MedTech Europe leaders Serge Bernasconi and Oliver Bisazza share their insights.
With all the effort that industry and regulators have expended over the past decade or so in negotiating and finalizing the new European Medical Device Regulation (MDR) to replace the previous Medical Device Directive (MDD), the players in this process can be forgiven for believing that the difficult work was completed when the new rules became effective last May. However, they are finding out the hard way that nothing could be further from the truth; in fact, some of the most arduous work still remains to be done.
