The MDR is a watershed. The requirements for market access of medical devices, for the life cycle of the product, and for notified bodies are increasing significantly. The new regulatory framework affects not only new medical devices, but also all proven and safe existing products, as well as specialty products, such as those for small patient populations. All Notified Bodies must go through a lengthy European designation process. The review time for the more extensive files is significantly increased.
The new EU regulation is already having a drastic impact on the medical technology market. BVMed conducted a survey on this in the fall of 2021, in which 88 member companies participated. More than 70 percent of BVMed member companies have already discontinued individual medical devices or entire product lines due to the new regulations brought about by the EU Medical Devices Regulation (MDR). Over 55 percent of the BVMed companies surveyed stated that previous suppliers had already discontinued their business activities due to the MDR.
Ahuge certificate backlogis looming
Almost nine months after the MDR came into force, the medical technology industry is still ready, but the system is not. There is still a dramatic capacity bottleneck at the notified bodies. There is a threat of a huge backlog of certificates in the next few years due to scarce resources that need to be put to better use. And not only that: innovations are coming to a standstill because research departments currently have to focus on the MDR regulations.
The pressure to act is growing. Notified bodies must channel and better utilize their capacities, focus on QMS audits and reviews of technical documentation in order to clear the certification backlog. In addition, pragmatic solutions must be established for existing and niche products.
BVMed sees the following possible solutions:
- The designation period for notified bodies must be shortened and incentives must be provided for new applications. All scopes must be sufficiently covered.
- The impending certificate backlog in May 2024 must be eased: Sufficient resources in the notified bodies are needed for this. The capacity must be used better and the priorities must be set correctly: in QMS audits and the review of technical documentation.
- Solutions must be established for manufacturers who demonstrably cannot find a notified body or whose existing contracts are terminated or not renewed. In addition, certificates that were issued with a shortened term should be extended to the normal term of five years.
- For proven and safe existing products, pragmatic solutions must be found, for example, via the “recognition of clinical practice” instrument.
- For niche or specialty products used in small patient populations, the EU Commission must create exemptions in Europe.
- To increase regulatory competence, funding programs should be set up and competence centers established – for example, for the planning and execution of clinical studies and the preparation of clinical evaluations and technical documentation. These support programs must not be limited to new developments and innovations, but must include existing products and be available to all players, including startups and SMEs.
- For market surveillance, we need an agile and digital “post-market surveillance” system to continue to ensure patient safety. This must involve the entire healthcare system: professional societies, hospitals, health insurance companies.
Conclusion: If SMEs are forced to shift their R&D resources to regulation at the expense of innovation activity, this shows that MDR has overshot the mark. We, therefore, need to develop MDR strategically. Companies, hospitals, and physicians are all in the same boat when it comes to care and safety.