"The variety of medical devices in Europe is in danger of dwindling. In some cases, it will not be possible to find alternatives on the market." This is the conclusion of a joint survey by the DIHKthe MedicalMountains GmbH and Spectaris on the consequences of the European Medical Device Regulation (MDR). The regulation has been binding in the EU since May 26, 2021 and replaces the previously established processes for placing medical devices on the market and making them available.
Unresolved problems
According to the survey, numerous existing products are being withdrawn from the market as a result because they are not (yet) certified in accordance with the new regulation. This problem extends across all 21 application areas surveyed. These include dentistry, trauma surgery, vascular and thoracic surgery, surgical instruments, neurology and orthopaedics and many more. In 16 of these, half of the companies active in these areas are discontinuing individual products, entire product lines or complete product ranges. Orthopaedic and classic surgical instruments are cited as examples. "The results of the survey show that the MDR is not practicable for manufacturers of medical devices in many areas," 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 an increase in the use of products that are not approved for this purpose," he points out. "Not to mention the difficult supply situation to which certain patient groups are exposed."
Declining willingness to innovate
The survey results also show negative effects on companies' innovation activities: almost every second company has put such projects on hold due to the MDR. One fifth of companies are switching to other markets, such as the USA or Asia, for the initial approval of their medical technology innovations due to the MDR. This could also result in R&D departments and clinical trials being relocated abroad. The coronavirus pandemic has shown how important an innovative healthcare industry is for Europe.
Obstacles to cooperation with "notified bodies"
Structural problems also make it difficult to implement the complete MDR system. The companies stated that they faced major hurdles when working with the notified bodies. In addition to a significant cost increase of 38% on average, with the cost increase for products in risk class III doubling to up to 99%, the duration of the assessment procedures has also increased, leading to an enormous delay in the provision of products. The high certification costs are causing major difficulties for small companies in particular.
A lack of capacity at the notified bodies is also an additional obstacle. At the time of the survey, less than half of the originally planned 59 notified bodies across the EU were still accredited to certify products under the new legislation. As a result, there are substantial bottlenecks in the necessary renewal of product certificates under the MDR, which in turn leads to the discontinuation of some products.
Pragmatic solutions required
From the industry's point of view, there is an urgent need to adapt the MDR. DIHK, MedicalMountains and Spectaris have therefore drawn up comprehensive recommendations for politicians: Old certificates that demonstrably could not be transferred to the MDR by the deadline of May 26, 2024 should be extended unbureaucratically in order to ensure the continued availability of these products. Pragmatic solutions must also be created to enable reliable implementation of the MDR. In addition to expanding the notified bodies, this also includes making the best possible use of their resources. This could be achieved through a shortened designation period and a modular approach to processing applications by the notified body
Furthermore, the development of special regulations for niche products and more pragmatic evaluation approaches for proven existing products are particularly necessary, especially with regard to the required clinical data. Such studies are often not even feasible due to ethical concerns or a lack of investigators.
Click here for the survey results.
Source reference "Survey on the EU Medical Device Regulation by DIHK, SPECTARIS and MedicalMountains"