EU regulatory framework for medical devices unsuitable for practical use

Whether surgical instruments, orthopedic products or visual and hearing aids: Many medical devices are already being withdrawn from the market as a result of the new European Medical Device Regulation (MDR), and numerous others will disappear by 2024 at the latest. This is shown by an initial assessment by German manufacturers of medical devices, in which 378 companies gave their views on the effects of the MDR.

Many problems still unresolved

The regulation has been binding within the EU since May 26, 2021, and has replaced decades of established processes for placing medical devices on the market and making them available. According to the survey, numerous existing products will be withdrawn from the market as a result - in all of the 21 areas of application surveyed. In 16 application areas or product groups, at least half of the companies active in these areas are discontinuing individual products, entire product lines or even complete product ranges, such as in orthopedics or classic surgical instruments.

"The results of the survey show that the MDR is not practical for medical device manufacturers in many places," says Martin Leonhard, chairman of medical technology at Spectaris. "However, if certain niche products are no longer available for medical care, this could lead to increased use of products that are not approved for this purpose," he points out. "Not to mention a difficult supply situation faced by certain patient groups, such as children."

Willingness to innovate also suffers

The survey results also show negative effects of the MDR on innovation activities of the companies: at almost every second company (46 percent), such projects are on hold due to the MDR, reports DIHK Deputy Managing Director Achim Dercks.

One-fifth of the companies (19 percent) are switching to other markets, such as the U.S. or Asia, for the initial approval of their medical technology innovations due to the MDR. "The Corona pandemic has shown how crucial a high-performance healthcare industry is, not only in economic terms," warns Dercks. "Policymakers must therefore focus more on maintaining the competitiveness and innovative strength of the medical technology industry - this will have positive effects on healthcare in the EU."

Hurdles in cooperation with "notified bodies"

In addition, structural problems complicate the implementation of the complete MDR system. According to the survey, the cooperation with so-called "Notified Bodies" required for market access faces significant obstacles. Companies not only experience significant cost increases of up to 100 percent when involving a Notified Body, but also more than double the duration of assessment procedures. As a result, the provision of products is massively delayed.

The high certification costs cause major difficulties for small companies in particular. "In addition to costs and duration, it is also the lack of capacity at the Notified Bodies that is basically cited as a major obstacle with regard to cooperation," says Julia Steckeler, Managing Director of MedicalMountains GmbH. "At the time of the survey, less than half of the originally planned 59 Notified Bodies (currently there are 28) had still been designated throughout the EU for the certification of products under the new law. This leads to substantial bottlenecks in the necessary renewal of product certificates under the MDR and requires fast, but also sustainable solutions that make the system permanently functional."

Pragmatic solutions are now required

From the industry's point of view, there is an urgent need for the legislator to adapt the MDR. DIHK, MedicalMountains and Spectaris therefore submit comprehensive recommendations for action: All legacy certificates that demonstrably cannot be transferred to the MDR by the deadline of May 26, 2024, should be extended without red tape in order to further ensure the availability of these products. Policymakers should also create pragmatic solutions that enable reliable implementation of the MDR. This includes not only the expansion of the notified bodies but also the best possible use of their resources.

Furthermore, the development of special regulations for niche products and more pragmatic assessment approaches for established existing products are particularly necessary, especially with regard to the required clinical data. The relevant studies are often not even feasible due to ethical concerns or a lack of investigators.

The complete survey results are available for download here:

First assessment of the German manufacturers of medical devices after the MDR came into force (PDF, 1 MB)