New VDE position paper outlines paths out of the looming medical technology chaos

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– Manufacturers face significantly increased documentation requirements with the new MDR
– VDE provides 32 recommendations in position paper
– Among other things, rolling reviews and remote audits are advocated

Since May 26, 2021, the European Medical Device Regulation (MDR) has been in effect. It regulates how medical devices—such as ventilators, syringes, or implants—can be brought to market in the European Union. After a year of practical experience, it becomes clear: especially for manufacturers, the regulation is far too complicated. Consequently, hospitals warn of supply shortages of vital medical products. The VDE has therefore today presented its position paper "European Medical Device Regulation (MDR): Recommendations for Implementing the Requirements" in a virtual press conference, which specifically addresses the problems in the practical implementation of the MDR and offers recommendations on where improvements are needed.

MDR is removing many medical devices from the market

Overall, VDE experts derive 32 recommendations for action from 17 subtopics of MDR implementation, aimed at the EU Commission as well as national competent authorities and funding bodies in the field of medical technology. It shows that the requirements that medical devices must meet under the new MDR have significantly increased and are also often ambiguously formulated. The documentation effort has increased so much that companies need to hire additional staff on a large scale. Currently, there are about 100 guidelines explaining the confusing and sometimes erroneous texts, and translation errors still exist across different language versions. "This particularly affects young, small, and medium-sized medical device manufacturers, who have limited resources; start-ups and newcomers are also facing difficulties. Therefore, the MDR is likely to lead to many medical devices and companies being unable to stay on the market," said Christian Otto Erbe, Managing Director of Erbe Elektromedizin GmbH and Deputy Chairman of the German Society for Biomedical Engineering in VDE (VDE DGBMT).

Rethink certification now

A major issue is also the certification process. Responsible for this are the so-called Notified Bodies, which must be notified under MDR—i.e., officially designated private certification organizations. The MDR has increased the requirements here as well, and notification now takes more time. This has resulted in fewer Notified Bodies so far than the number that were notified under the (old) medical device directives. Dr. Cord Schölteburg, Head of VDE Health, pointed out that many manufacturers are currently struggling to find a Notified Body with available capacity: "It would make sense to introduce an EU service center for available capacities. Additionally, a 'wave' of recertifications of existing products is looming at the end of the MDR transition period on May 26, 2024, which will lead to further capacity shortages. The VDE recommends conducting rolling reviews—i.e., phased certification—and making consistent use of remote audits."

Furthermore, the EU Commission should find a realistic approach to documentation requirements, especially regarding the clinical evaluation of existing products, whose certificates issued by the Notified Body are still valid until at most May 26, 2024. An extension of the transition period could be considered here concerning the delivery of clinical data within the framework of Post-Market Clinical Follow-Up (PMCF). A MDR-compliant certificate from a Notified Body could then be issued as part of a rolling review, contingent on this still-to-be-provided evidence.

EUDAMED still not operational

For Prof. Dr.-Ing. Jens Haueisen, Head of the Institute for Biomedical Engineering and Informatics at TU Ilmenau and Chairman of the VDE DGBMT, it is also incomprehensible why the European database for medical devices, Eudamed, is not yet fully operational, despite its crucial role under the new MDR. Eudamed is intended to serve as an information base for marketed medical devices and as a foundation for extensive registration obligations. The EU has not delivered on this: of six database modules, only three (partially) are currently available. Additionally, the technical design of Eudamed is outdated and only conditionally user-friendly. The VDE therefore calls for the rapid establishment of full functionality of the European medical device database.

AI-based medical devices disadvantaged

Manufacturers of AI-based medical devices still feel disadvantaged, as they are likely to face further laws in the EU (draft laws Artificial Intelligence Act, AIA, and Artificial Intelligence Liability Act, AILA), which will impose not only additional requirements but also "double standards." It should be considered whether medical devices could be exempted from additional laws in this area.

"If the EU Commission does not act quickly, many medical technologies 'Made in Europe' risk not entering the market anymore—with fatal consequences for patients," warned Haueisen. Therefore, the VDE also recommends a comprehensive assessment of the actual impact of MDR on patient care. Regulation is important, but it must not prevent patients from benefiting from new medical devices.