New Voices Clamor For Urgent MDR Action To Avoid Major Clinical Crisis
Industry and notified bodies have long warned of the hurdles to implementation of the Medical Device Regulation. Now competent authorities and medical and research societies are adding to the pressure for the EU to find solutions fast.
You may also be interested in...
MDCG Throws Ball Back Firmly In Manufacturers' Court As Pressure Grows For MDR Solutions
EU manufacturers who delay applying to notified bodies for conformity assessment of their medtech products well in advance are being held accountable for implementation problems with the EU Medical Device Regulation.
Is The Implementation Of The EU Medtech Regulatory Structure Entering A New Phase?
Three weeks have gone by now since the European Commission published a “latest update” on the medical device sector pages of its website. What does this mean for the sector?
How And Where Tougher Clinical Evaluation Measures Under EU MDR Cause Challenges
A first of its kind study examines how large compared with medium companies are coping with the EU’s strict clinical evidence requirements. The results show how it is the more stringent demands for high-risk devices that are leading to device removals as well as market launch outside the EU.