MDR removes many medical devices from the market

The European Medical Device Regulation (MDR) has now been in force for over a year - and it is clear that the regulation is far too complicated, especially for manufacturers. As a result, hospitals are warning of bottlenecks in the supply of vital medical devices. The VDE has therefore drawn up a position paper with recommendations for implementing the requirements, which specifically identifies the problems with the practical implementation of the MDR and makes recommendations on where it should be improved.

In total, the VDE experts derive 32 recommendations for action for the EU Commission as well as for the national competent authorities and funding bodies in the field of medical technologies on 17 sub-topics of MDR implementation. This shows that the requirements that medical devices must fulfill have increased significantly and are also unclear in many areas. The amount of documentation required has increased to such an extent that companies are having to employ a considerable number of additional staff. There are already around 100 guidelines explaining the incomprehensible and sometimes incorrect text, and there are still translation errors in the different language versions. "This affects young, small and medium-sized manufacturers of medical devices in particular, who only have limited resources, and start-ups and newcomers are also having a hard time. The MDR will therefore in all likelihood mean that many medical devices and companies will not be able to survive on the market," said Christian Otto Erbe, Managing Director of Erbe Elektromedizin GmbH and Deputy Chairman of the German Society for Biomedical Engineering in the VDE (VDE DGBMT).

The certification process is also a major problem. This is the responsibility of the so-called Notified Bodies, which must be notified in accordance with the regulation, i.e. state-appointed private testing organizations.
The MDR has also increased the requirements here, and the notification process takes longer. As a result, the number of notified bodies has so far been lower than the number notified under the (old) medical device directives. Dr. Cord Schlötelburg, Head of VDE Health, pointed out that many manufacturers are currently finding it difficult to find a notified body with free capacity: "Here
It would make sense to introduce an EU service point for free capacities. In addition, there is a threat of a 'bow wave' of recertifications of existing products at the end of the MDR transition period on May 26, 2024, which will lead to a further capacity bottleneck.
capacity bottleneck. The VDE recommends carrying out rolling reviews here, i.e. gradual certification. It should also be possible to make consistent use of remote audits."

Furthermore, the EU Commission should find a realistic way of dealing with the documentation requirements, especially for the clinical evaluation of existing products whose certification by the notified body is still valid until 26.05.2024 at the latest. An extension of the transitional period would be conceivable here with regard to the provision of clinical data as part of the post-market clinical follow-up (PMCF). An MDR-compliant certificate from a notified body could then be issued as part of a rolling review, subject to this evidence still having to be provided.

Jens Haueisen, Head of the Institute of Biomedical Engineering and Informatics at Ilmenau University of Technology and Chairman of the VDE DGBMT, also finds it incomprehensible why the European database for medical devices Eudamed, which will play a key role under the new MDR, is not yet fully operational. Eudamed is intended to serve as an information base for medical devices placed on the market and as a basis for extensive registration obligations. The EU has not yet delivered on this: Of six database modules, only three are currently (partially) available. In addition, the technical design of
Eudamed is not up to date and only partially user-friendly. The VDE is therefore calling for the European medical device database to be made fully functional as quickly as possible.

Furthermore, manufacturers of AI-based medical devices feel they are being left behind, as they are likely to be faced with further legislation in the EU (draft legislation Artificial Intelligence Act, AIA, and Artificial Intelligence Liability Act, AILA) and will therefore not only be confronted with more but also with "double requirements". It should be considered whether medical devices could be exempted from additional laws in this area. "If the EU Commission does not act swiftly, many medical technologies 'Made in Europe' are at risk of no longer coming onto the market - with fatal side effects for patients," fears Haueisen.