Stakeholders request revision of the regulation
Biomedical engineering: European Medical Device Regulation is a handicap for the innovation hotspot Germany
Patient safety is top priority in medicine and biomedical engineering. Aiming to increase patient safety, the EU introduced the European Medical Device Regulation (MDR) in 2017. During a conference organized by the Fraunhofer High-Performance Center Translational Biomedical Engineering, headed by the Fraunhofer Institute for Toxicology and Experimental Medicine ITEM, experts, representatives from small and medium enterprises, the chairmen of the boards of directors of the academic umbrella organization DGBMT and the industry association BVMed, and representatives from acatech and the VDE Society Microelectronics, Microsystems and Precision Engineering (GMM) discussed challenges and consequences of the MDR. They are expecting massive negative consequences from the regulation and are suggesting specific measures for a revision of the MDR.