French & German warning: EU must extend MDR transition period. BVMed and SNITEM have collectively issued a warning about the potential of patient care collapsing across the EU. BVMed is the German Medical Technology Association. SNITEM is the French Medical Technology Industries Association.
SNITEM and BVMed are seeking for major changes following a meeting with European Commission representatives in Paris on March 14, 2022.
Not Enough Notified Bodies
It is clear that the number of Notified Bodies available is insufficient. Therefore it is hard to conduct the required conformity assessments under the new standards. For the most part, this is one of the main difficulties in the transition to a new medical device regulatory framework. As a matter of fact, the current transition is posing significant challenges for manufacturers attempting to comply with the new requirements with their existing medical devices. Reportedly, it is already having a negative influence on health services. This is one of the main issues in the coöperative French & German warning.
Postponement After Postponement
In spring 2020, the European Commission postponed the MDR’s Date of Application (DoA) by a year. The EC acknowledged that there could be severe issues. As the deadline for the IVDR’s DoA approached, the EC was obliged to take a similar action in December 2021. In fact, the EC extended the IVDR transitional periods for most in vitro diagnostic medical devices (IVDs). Obviously that was to give business more time to comply. This came after a powerful statement from key individuals in the European pharmaceutical industry. They warned that vital IVDs for cancer detection would be driven off the market if new conformity assessments could not be secured in time.
Press Release for Joint French & German Warning
Nonetheless, it is obvious that Notified Body capacity is not growing fast enough. It can’t keep pace with the increasing demand for conformity evaluations. In the most recent dramatic turn of events, SNITEM and BVMed issued a press release. At the moment this is only available in French and German. They announced a Franco-German initiative to avert a crisis in patient care. Evidently a crisis caused by a lack of medical device availability under the new framework. Furthermore they urge the European Commission and “other concerned actors” to take immediate action to grasp the situation. The trade groups are concerned about a “collapse” of patient care, according to the news release. Another wake-up call should come in the form of a letter like this from key European industry organisations.
SNITEM and BVMed Call for Changes
Significant expansions to the MDR transitory periods will likely attract the most attention:
- firstly, two years for Class III and implantable medical devices, and
- secondly, four years for all others.
Indeed, these proposed measures are there to keep existing medical devices on the European market. This, by taking a “lighter touch” approach to conformity assessment. This is much like granting “grandfathering” to some “old” medical devices. This would be similar to the IVDR’s tapering transitory periods, which were recently amended. Furthermore, the French & German warning calls upon for more changes:
- Expanding the capacity of Notified Bodies through:
- lowering the time it takes to designate new Notified Bodies,
- streamlining the Notified Body designation process, and
- creating incentives for new organizations to become Notified Bodies;
- To conduct conformity checks, make better use of current resources. SNITEM and BVMed aren’t really clear on what this signifies, but they offer a few possibilities:
- Post-market surveillance of “legacy” medical devices could be more “sensible” (at least in the short term);
- the use of “conditional” conformity assessment certificates, which allow manufacturers to supplement dossiers with post-market data to support conformity;
- the use of “second look” consultation and scrutiny procedures (in Article 54); and
- the establishment of specialist rules for niche products (presumably to allow those niche products to be fast-tracked through conformity assessment).
‘Lighter Touch Approach’ to Conformity Assessment
This appears to be the case where SNITEM and BVMed call for more intelligent use of existing resources.
Will the EU Respond to this French & German warning?
It will be interesting to see how and whether the EU responds to this call to action. Meanwhile, the passing of time continues. In two months, the IVDR’s DoA will arrive. The first anniversary of the MDR’s DoA is near, and the remaining time under its transitional periods is ticking away. We expect this latest intervention by SNITEM and BVMed to result in some form of regulatory leniency from the EU. For this reason, the industry should not abandon its efforts to adapt to the new standards.