We’ve written extensively on this blog about the difficulties being faced in Europe as we transition to a new medical device regulatory framework. It has long been apparent that there is not nearly enough Notified Body capacity to conduct the necessary conformity assessments under the new regulations and that this is creating serious difficulties for manufacturers trying to bring their existing medical devices into compliance with the new regulations. In turn, as mentioned below, this is already adversely impacting the provision of healthcare.
The European Commission first conceded that there might be serious problems in spring of 2020 when it postponed the Date of Application (DoA) of the MDR by a year to May 2021. As the DoA of the IVDR loomed ever nearer, the European Commission was again forced into a similar step in December 2021, extending IVDR transitional periods for most in vitro diagnostic medical devices (IVDs) to reduce the time pressure on industry to bring its devices into conformity. This followed a striking intervention by major figures in the European pharmaceutical industry, who raised the alarm about patient deaths if essential IVDs for the detection of cancer were forced off the market because new conformity assessments could not be obtained in time.
Despite these steps, it is still clear that Notified Body capacity is not increasing fast enough to meet the increasing demand for conformity assessments. In the latest dramatic turn of events, SNITEM and BVMed (the French and German trade associations for the medical technology industry) issued a press release (only in French and German for now) announcing a Franco-German initiative to avert a crisis in patient care caused by the lack of availability of medical devices under the new framework, and called on the European Commission and “other concerned actors” to take urgent steps to grasp the situation. The press release makes clear that the trade bodies are concerned to avert a “collapse” of patient care. A message as blunt as this from major European industry bodies should be yet another wake-up call.
Following a (presumably pretty challenging) meeting with representatives of the European Commission in Paris on 14 March 2022, SNITEM and BVMed are calling for some major changes. The change that will likely attract the most attention is significant extensions to the MDR transitional periods: two years for Class III and implantable medical devices and 4 years for all others. This would be akin to the tapered transitional periods already introduced in the IVDR by recent amendment.
SNITEM and BVMed also call for a number of other interesting changes:
- Expansion of Notified Body capacity, by reducing the time to designate new Notified Bodies, by streamlining the Notified Body designation process, and by putting in place incentives for new organisations to become Notified Bodies;
- More intelligent use of existing resources to conduct conformity assessments. SNITEM and BVMed are not very specific as to what this means, but they make a number of suggestions:
- post-market surveillance of “legacy” medical devices could be more “sensible” (presumably this means less onerous, at least in the short term);
- the use of “conditional” conformity assessment certificates allowing manufacturers to supplement dossiers with post-market data to support conformity;
- limiting the use of “second look” consultation and scrutiny procedure (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).
To the extent these suggested measures are intended to keep existing medical devices on the market in Europe by taking a “lighter touch” approach to conformity assessment, which appears to be the case where SNITEM and BVMed call for more intelligent use of existing resources, this sounds a lot like a form of grandfathering of some “legacy” medical devices.
It remains to be seen how and whether the EU will respond to this call to action. Meanwhile, time marches on. The DoA of the IVDR will arrive in two months. The first anniversary of the DoA of the MDR is also approaching, and the time remaining under its transitional periods continues to tick down. Industry must not let up in its efforts to adjust to the new regulations in the hope that this latest intervention by SNITEM and BVMed could result in some sort of regulatory forbearance from the EU.