German Industry Says MDR Implementation 'Too Slow' But Negative Economic Effects Still Largely Unreported

Germany’s CorTec has implanted its wireless brain-computer interface in a stroke patient, launching a trial to test safety and whether brain stimulation during physical therapy can help restore movement where traditional rehab has failed.

Now that the US FDA has chosen not to appeal a March ruling effectively killing the agency’s efforts to regulate lab-developed tests as medical devices, will the agency adopt a different strategy to flex its regulatory muscle?

Less bureaucracy, no more national supply chain law, framework agreements and competition for direct reimbursement of medtech innovations are among the positive changes the local medtech industry might expect as Germany’s new government gets down to work. Life sciences lawyer Gunnar Sachs offers a view from the ground.

A change of government, hospital reform and a drive towards healthcare digitization are keeping German medtech manufacturers on their toes. Making the MDR more user-friendly and winning support for a medtech strategy are arguably bigger priorities. US export tariffs have also pushed their way onto the agenda. BVMed chief executive Marc-Pierre Möll puts it all into context.