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.
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Will Commission heed COCIR’s Comprehensive And Sometimes Radical Solutions To MDR Delays?
Industry’s timely compliance with the EU’s new medtech regulations is under threat. Will the European Commission consider potential solutions from COCIR as a persuasive factor for change?
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.
Annex XVI Products Set To Have More Time To Comply With MDR
Devices without a clinical purpose that fall under the scope of the EU’s Medical Device Regulation need to be tightly regulated. Now it looks as though manufacturers will have more time to comply if they need it.