Commission Optimistic Over EU MDR Readiness While Others See A Flawed System
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.
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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.
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.
The European Commission has updated its figures on the status of readiness of notified bodies under the Medical Device and IVD Regulations. Three more designations are imminent, but just one under the IVDR.