Commission Optimistic Over EU MDR Readiness While Others See A Flawed System
Executive Summary
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.
You may also be interested in...
SMEs Buffeted About By EU MDR Delays Will Not Be Able To Financially Sustain Products
Companies are being told not to leave compliance with the EU’s MDR until the last minute. But many have no choice because of financial constraints and notified body capacity.
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.
EU Regulatory Roundup, March 2024: Busy Agenda In Broad Range Of Key Areas
March was an important month for EU medtech regulation with an interesting spread of news relating to the Medical Device and IVD Regulations, the Batteries Regulation, the Artificial Intelligence Act and more.