The last few months have brought a flurry of MDR regulatory and legislative activity, causing a morass of confusion. In this interview, leading EU medtech lawyer Erik Vollebregt clarifies what the recent spate of proposals and guidances means for product companies and how they should manage in these uncertain times, outlining what the future looks like for medtech regulation in Europe.
Usually the year’s end is a quiet period in terms of regulatory and legislative activity with most people focused primarily on enjoying the holidays, but this year proved anything but calm in the EU when it came to the Medical Device Regulation (MDR). The concerns that the industry has long been raising regarding an impending crisis following the expiration of the latest grace period for legacy products whose CE mark certifications under the old Medical Device Directive (MDD) are set to expire in 2024 without receiving new MDR clearance—due to an imminent bottleneck caused largely by a lack of sufficient notified body resources—appear to have finally become a top priority for European authorities. This better-late-than-never reaction is fueled by the likely result the EU is facing: a potential withdrawal from the marketplace of tens of thousands of legacy devices that patients, clinicians, and hospitals rely on for medical treatment, and that doesn’t take into account the potential impact on new, innovative technologies that are also awaiting notified body clearance.
This sudden outburst of concern prompted a flood of activity on all fronts, triggered by the December 9 EPSCO meeting of the European health ministers that resulted in suggestions that were widely misinterpreted as law. Along with that came a bustle of recommendation gain, not to be confused with rules that have the force of law by the Medical Device Coordination Group, an organization of EU health authorities created by the MDR to help administer the new regulations. Those were followed on January 6 by an actual legislative proposal by the European Commission—although still not carrying the force of law—extending MDR through 2027 and 2028 based on device risk. [Editor's note: On February 15 2023, after this interview was conducted, the European Parliament passed these MDR extensions/transition periods for legacy devices and removed the sell-off period that is discussed here. The next step is for the EU Council to formally sign off on it which they have already said they will do without amendments, after which it will be published in the Official Journal to enter into force of law, which could take place shortly. Key questions remain to be decided, including the status of devices labeled with expired certificates that rely on the CE marks for access to non-EU markets. For more, see Pathways’ Picks, February 15, 2023.] And all through this bout of activity, the Internet and social media were abuzz in consultants’ recommendations, some accurate, but many not, leaving many in the industry—especially those not familiar with the inner workings of the EU parliamentary system—thoroughly confused about what had just happened and what they were likely looking at in the immediate future in terms of European medtech regulation.
In this interview, we turn to Erik Vollebregt, a leading medical device attorney with the Axon law firm in Amsterdam, to sort all of this out for us and advise as to where things are heading with MDR.