Likely EU MDR Postponement: EU Finally Sees the Light
by Steve Gompertz, QRx Partners
If you’re involved in the medical device industry, you’ve likely heard recently that the EU is considering extending the enforcement deadline for compliance with the Medical Device Regulations (MDR). Before you celebrate or decide to put your MDR transition projects on hold, there are some details and background to be aware of.
It’s always good to start by understanding what led up to this. When the MDR first went into effect, while intended to create a more robust framework for ensuring public safety, it also created a perfect storm of conflicting requirements. The MDR established more burdensome requirements not only for Manufacturers and other “economic operators” but also for the Notified Bodies that would be accredited to enforce them. It would seem logical to ensure that those entities that will enforce the regulation can demonstrate their ability to do the job well. However, the path to accreditation was so tough that many Notified Bodies decided just to drop out, and those who chose to stay in the game found the path difficult and lengthy. Manufacturers were then faced with a complex and long path of their own, coupled with a lack of options for getting certified. A client recently shared that their Notified Body told them that they were scheduling certification audits out 18 months!
The result is that a significant number of medical devices will not be able to stay on or be introduced into the EU market; over 60% of existing devices are on the market by some estimates! Obviously, this does not serve the citizens of the EU well. Talk about a dangerous supply chain issue!
So, last week at a meeting of the EU Employment, Social Policy, Health, and Consumer Affairs Council (ESPCO), the EU Health Commissioner announced her intent to formally propose amendments to the EU MDR in January 2023. The good news is that none of the ESPCO ministers objected.
So, what might change?
First, the deadline for complying with the MDR would be pushed out to 2027 for higher-risk devices and 2028 for medium and low-risk devices. The good news is that one minister suggested making it less complex and postponing all device classes to 2028. There is a catch though: devices must not have known safety issues or undergo significant design or intended use changes. This also implies that the EU would authorize Notified Bodies to extend the expiration dates for existing CE Mark certificates. However, the other big catch is that Manufacturers must still submit their MDR applications to a Notified Body by the original deadline of May 26, 2024. In other words, Manufacturers need to demonstrate commitment to transitioning by the new deadline.
The other really interesting and important change proposed is the elimination of the so-called 2025 “sell-off,” where Manufacturers would have to remove from the market any devices that had been CE marked under the MDD and had not been re-certified under the MDR. Luckily, logic has prevailed in that the ministers realized that if a device was deemed safe to market under the MDD, what would make it suddenly unsafe just because the regulations changed?
What happens in the meantime?
The EU Health Commissioner also recognized that in the time between proposing the amendments and them going into effect, some Manufacturer's certificates might be expiring. So, the EU Medical Device Coordination Group (MDCG) has now published a Position Paper explaining to Notified Bodies how to handle this situation so that Manufacturers are not forced to remove devices from the market.
Again, while this is all essentially good news, Manufacturers shouldn’t back off efforts to transition to MDR compliance. That path will still be a significant amount of work, and the time will disappear quickly, even with the extended deadline(s). Don’t get complacent!
If you’re struggling with how to make the transition to the EU MDR, QRx Partners can help. Contact us at Contact@QRxPartners.com or 833-779-7278.