MDR Is The ‘Mother Of European Industry’s Problems’ − Germany's BVMed At Medica 2023
One in 10 German medtechs will not survive the €7bn+ journey to EU regulatory compliance
Higher logistics and energy costs are putting medtech P&Ls under pressure, and compliance with the EU MDR is draining any remaining surplus. Sustainability compliance is another cost to factor in, says BVMed chief executive Marc-Pierre Möll in part 2 of his interview with Medtech Insight at Medica 2023.
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While revenues are looking healthier at last, a host of issues in the post-COVID readjustment phase still weigh heavily on medtech manufacturers in Germany, chief among which is EU and national over-regulation. Hospital reform and the digital shift are also on a long list of priority issues to monitor and tackle if Germany’s industrial base is to remain preeminent, said BVMed chief executive Marc-Pierre Möll.
New supply chain due diligence rules came into force this month in Germany, ensuring that every commercial business over a certain size respects social and environmental criteria. The medtech industry is receiving practical compliance advice.
The trend among device innovators to focus on diagnostic technologies that improve imaging, offer better visualization of tissues and avoid the need for biopsies is well noted by full-service law firm CMS. Its equIP program supports many start-ups incorporating AI into products and development processes.