TEAM-NB Highlights Survey Figures Suggesting Massive 2024 Bulge In MDR Applications
Growing evidence demonstrates the one-year delay to the Medical Device Regulation, plus the expansion of the scope of products that could remain on the market beyond the MDR date of application, have simply pushed problems to 2024.
You may also be interested in...
EU Regulatory Watershed Sees Widely Diverging Expert Views Over MDR As They Bid Farewell To Directives
Today marks the end of an era. Directives that have defined our working days for decades will now recede into history. Some have spoken of their nostalgia, some of optimism, and others of concerns. For one regulatory veteran, meanwhile, EU medtech is heading in the wrong direction.
A regulatory system that cannot function as intended, even with an extra year for preparation, will become mandatory in the EU next week. German medtechs suggest a route forward.
The European Commission is satisfied with the state of readiness of the EU MDR, but for TÜV-SÜD’s Sabina Hoekstra-van den Bosch the system is like a well-trained athlete who is prevented from competing properly.