Since the end of May 2021, the new EU regulation “Medical Device Regulation (MDR)” has to be implemented. A survey by the Association of German Chambers of Industry and Commerce (DIHK) found alarming consequences of the regulation.

What is the aim of the Medical Device Regulation?

The MDR aims to ensure that medical devices are reliable. The discussion about new, stricter legislation was initiated by health problems affecting patients with breast implants. A doctor had used materials for the implants that were not approved for this purpose. The regulation is therefore intended to increase patient safety. To this end, a whole series of measures was decided, including a new labeling for all medical devices and the monitoring of the products after they are launched on the market.

Current implementation issues

As it turns out, the complete conversion of the old system to the new requirements of the MDR did not happen without side effects. As the DIHK informs, numerous medical products are disappearing from the market because their certificates are no longer valid. Among other things, baby stents and radiofrequency perforation catheters for the treatment of stuck heart valves in newborns are affected.

The DIHK therefore calls for special regulations for niche products. In addition, measures are needed to make innovations in the industry attractive again. The costs for this have risen sharply as a result of the regulation.

Source: DIHK (german)