Thursday, February 22, 2024, 11:50 a.m
Berlin – In its statement on the draft medical research law, the European Manufacturers’ Association for Medical Compression Therapy and Orthopedic Aids (eurocom) welcomes the goal formulated therein of facilitating the development, approval and manufacture of medical devices. However, eurocom believes it is urgently necessary not only to think about the requirements of large companies in the field of drug research and medical technology, but also to take small and medium-sized companies (SMEs) into account.
Oda Hagemeier, Managing Director of eurocom, explains: “The manufacturers of medical aids are largely medium-sized. In many cases these are family businesses that have been an important regional economic factor for several generations and have great medical innovation power while at the same time having limited resources. Research and development of medical devices in Germany poses considerable financial and organizational challenges for medical device manufacturers. This must definitely be taken into account in the Medical Research Act.”
In two respects, eurocom particularly positively assesses the intended simpler approval of imaging procedures that demonstrate the effectiveness of medical aids and can ensure their integration and further development for new medical procedures. “On the one hand, this strengthens Germany as a research and development location and, on the other hand, it benefits patients, to whom new medical aids can be made available more quickly,” said Hagemeier.
Eurocom suggests examining an alternative to the establishment of a Federal Ethics Commission. There are concerns, for example, about the connection to the Federal Institute for Drugs and Medical Devices as the approving body for clinical studies. Hagemeier said: “This could have negative consequences for the independence of the Federal Ethics Commission. In addition, the addition of a new additional level hardly simplifies a procedure. And that’s what the bill is about.”
Here You can find the complete statement from eurocom.
About eurocom
eurocom is the manufacturer association for compression therapy, orthopedic aids and digital health applications. The association sees itself as a designer and dialogue partner in the healthcare market and is committed to spreading knowledge about the medical benefits, effectiveness and cost-effectiveness of compression therapy and orthopedic aids. In addition, eurocom is developing concepts on how the supply of medical aids can be ensured currently and in the future. Almost all European companies operating in the German market in the areas of compression therapy and orthopedic aids belong to the association.