Assessment after two years: MDR burdens Germany as a business location - Survey on MDR by Spectaris, DIHK and Medical Mountains

Whether surgical instruments, cardiac catheters for newborns or emergency ventilators: After two years since the introduction of the Medical Device Regulation (MDR), German manufacturers are taking stock of the situation. In a joint survey conducted by the German Chamber of Industry and Commerce (DIHK), Medical Mountains GmbH and the industry association Spectaris, almost 400 companies commented on the effects of the MDR.

Great concern: Many medical devices are disappearing from the market

The MDR, according to the results, means that many medical devices are already being withdrawn from the market. Many more are at risk of disappearing by 2027. Three quarters of the companies surveyed reported a negative impact on their innovation activities. In more than every second product portfolio, individual products or entire productions and product ranges are being withdrawn from the market. All 21 application areas surveyed are affected.

High costs and bureaucracy weigh on medical technology companies

Although the transitional periods for existing products were extended until 2027/2028 at the end of 2022, this does not change the structural problems. On the contrary: the assessment from the first joint survey in spring 2022, according to which the MDR is still not practicable, has even been confirmed. Almost all companies (97%) continue to have problems with implementation, particularly due to the high cost and administrative burdens. At 67%, the cost of adapting technical documentation is at the top of the list of challenges. Costs here have risen by an average of 111%.

Niche products often no longer cost-effective due to MDR

The cooperation with notified bodies required for market access also faces considerable obstacles, according to the survey. Companies report average cost increases of 124% when involving a notified body. In 91% of cases, it is the full certification costs that are the deciding factor in withdrawing medical devices from the EU market. Niche products with a small sales market in particular can no longer be marketed economically. The duration of procedures is also increasing drastically for many companies. For 37% of companies, the duration of procedures is even three times as long as before the MDR. As a result, the provision of products is massively delayed.

In view of these developments, Achim Dercks, Deputy Managing Director of the DIHK, warns: "Politicians must maintain the competitive and innovative strength of the medical technology sector, which is characterised by medium-sized companies, and focus more strongly on it. This would also be important for reliable healthcare in the EU.

USA more attractive than EU for new registrations

This development also harbours fuel for further social debate. Also because the EU is no longer the undisputed number one for new registrations.  More than one in five companies is switching to other markets for medical technology innovations - mostly to the USA. „These results hold up a mirror to the EU,“ says Julia Steckeler, Managing Director of Medical Mountains GmbH.

If the USA is given preference due to its faster authorisation procedures, predictable costs and reliable regulatory requirements, it is quite clear what needs to be worked on.

The system still has too many construction sites, she says.

Associations see need for action from politicians

Martin Leonhard, Chairman of Medical Technology at Spectaris, adds: "For the industry and patients, action is now required from politicians“. Germany and the entire EU are at risk of being left behind - on the one hand in international competition, and on the other in the supply of innovative, but also specialised and proven medical products. The situation of the many small companies is particularly worrying. These companies generally have fewer financial and human resources at their disposal.

Spectaris, Medical Mountains and the DIHK are now using the report to enter into further political dialogue. The figures must now prompt Brüssel to act quickly and lead to pragmatic, fundamental steps in the short term, the initiators demand. Sitting out is no longer an option: once medical products and research and development expertise have been lost, they can only be recovered with great difficulty, and probably not at all.

For the results of the survey: www.dihk.de

Article from "medizin & technik" from 05/01/2024