Berlin. Healthcare industry representatives warn against over-regulation of the medical device industry. Medical technology companies have been under pressure with the complex recertification of their products in the EU, they explained this Wednesday at a hearing by the Bundestag Health Committee on a proposal from the Union parliamentary group on the subject.
The Union faction calls for a sustainable strengthening of the healthcare industry. The industry has been preparing for the change to the EU Medical Device Regulation (MDR) for years. Implementation costs are estimated at seven to ten billion euros. One of the main problems is capacity bottlenecks in notified bodies, which must be included as part of the conformity assessment procedure, as the Bundestag hib information service reports.
The Federal Medical Technology Association called for reduced bureaucratic effort, greater efficiency, accelerated procedures for innovations, and special procedures for orphan devices. A spokeswoman for the association complained at the hearing that there were too many actors and responsibilities and too much redundancy. She called for further development of the MDR in order to resolve structural problems.
The National Association of Statutory Health Insurance Funds highlighted that the MDR serves the objective of improving patient safety. When it comes to medical devices, there is currently no systemic supply bottleneck. The main current problem is the “delay in certification” of existing medical products, which began during the corona pandemic. Solutions have now been found to reduce the certification delay and give companies more time to make the change. (eb)