Concerns about shortages of orthopaedic implants due to the EU Medical Device Regulation

The German Society for Endoprosthetics (AE) is concerned about potential shortages of artificial hip and knee joints. Bureaucratic hurdles urgently need to be removed, as otherwise the EU Medical Device Regulation (MDR) would increasingly jeopardize patient safety, it said today.
The MDR, which came into force in 2021, has been criticized since its inception and the warnings issued at the time seem to be increasingly coming true: Specialized medical devices in particular, which are manufactured in small quantities, are increasingly disappearing from the supply chain.
In addition to reducing bureaucratic hurdles, the association is therefore also calling for a simplified approval and recertification process in order to safeguard care and continue to enable innovation. Only this would make it possible to bring implants for special requirements onto the market quickly and unbureaucratically and ensure modern and patient-oriented medical care.
Author(s) Source
lau/ 16.02.2024 (german original)
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