Snitem in France and BVMed in Germany have requested a minimum of 2 years extension for transitioning to the EU Medical Device Regulation. These are 2 of the most important medtech organizations in Europe and their members make up more than half of the medical device market in the EU.
The transition period, which was planned to be over by the end of May 2024, is not long enough, according to Snitem and BVMed. These companies have concerns that patient care is likely to ‘collapse’ if the process is rushed or shortcuts are taken.
According to the medtech groups, the extension should take place in 2 stages. The first stage would address higher classified products, such as implantable and Class III devices, and this would be completed within 2 years.
The second stage would address every other product and this would take closer to 4 years. This split strategy would ensure that all medical products would remain available.
The MDR has been functional since May 2021 but Snitem and BVMed claim the regulations were not completely operational which results in tying up a lot of already scarce medtech resources plus the current capacity of just 27 notified bodies, also known as NBs. Medical device manufacturer trade groups as well as NBs are not convinced about the limited capacity for product certification under MDR.
Significant Backlog of Required Certificates
According to the German and French trade organizations, although MDR went into effect back in 2021, major parts of the required infrastructure less than fully operational. This results in significant challenges for the smaller medtech companies who are approaching their limits of what is possible considering existing and new device certification.
Not even 1,000 of the 25,000 required certificates have been transferred to the MDR yet, according to trade groups, which is a worry since the average certification process duration is 18 months.
Trade groups warn that by Q3 2022, decisions have to be made concerning which products have to be withdrawn from the EU marketplace, as the MDR transition period is currently set to end on May 26, 2024.
Since there are only 27 notified bodies in total, being able to get more products certified in such a brief time period and checking the associated extensive documentation does not seem feasible, according to medtech companies.
Further Recommendations to Address the Backlog
BVMed and Smiten are calling not only for an extension in the MDR transition time but also for notified bodies to extend their capacity. In addition they call on NBs to offer equal access to every manufacturer to solve the backlog.
The designation period for NBs must be shortened, incentives put in place for applications and any ongoing assessments streamlined, according to Smited and BVMed.
Other European medical device groups are weighing in with their own concerns about the potential of MDR to face problems with the EU infrastructure, resulting in a disrupted product supply.
Although the regulatory regime was rolled out last year, MedTech Europe has warned that there are potentially severe challenges to solve which could impact the whole sector, including NB limited capacity. This would be especially true for innovative and new device certification.
If no changes are made, it is believed that the sector will be unable to supply certified devices without delays and other problems, which would ultimately negatively impact the end consumer.
There are many small and medium companies in the field who contribute a large percentage of medical device innovations in Europe, according to MedTech Europe when MDR went into effect in May 2021.