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.
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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.
Artificial intelligence is incorporated into medical devices and IVDs with increasing frequency. But it is only now that the EU is working on how that process will be regulated.
For the first time in nine years, the European Commission looking at the extent to which IFU for medical devices may be made available electronically.