How Notified Body Notifications Could Handicap Parts Of The Medtech Industry
Executive Summary
EU industry association MedTech Europe explains how the first-come, first-served approach to notified body notification threatens to disadvantage some in industry.
You may also be interested in...
What We Know About Notified Body Appointments: Useful Insights Into Timings And Capacity
When will notified bodies be appointed? How many will there be? Where are the problem areas? And what are the resource issues? MedTech Europe's Oliver Bisazza answers these and many more critical questions.
Reading Between The Lines: Is There A Positive Message Hidden In MDCG’s Blame Document?
The hope is now that a new EU document will be issued to address head on the scale of bottlenecks at notified bodies and of products needing to be removed from the market.
Commission Offers Glimpse Of Actions To Speed Up MDR Compliance
With a sense of desperation building among stakeholders over the challenges in ensuring all products are compliant with the Medical Device Regulation in time, high-level solutions are being considered. But a further MDR delay is not an option.