There is now even more urgency for medtech companies, including small firms, to employ the services of EU27 notified bodies – with UK notified bodies set to have their conformity assessment roles temporarily withdrawn if the UK leaves on March 29 without a deal.

Meaningful medtech advances that have the potential to revolutionize patient care cannot happen by eliminating risk entirely, but it’s a balance that European stakeholders are failing to achieve consistently. This is so in Germany too, says the BVMed industry association, with negative consequences for those at the sharp end of innovation – the SMEs and start-ups who originate a vast proportion of medtech advances.

Notified body and medtech industry trade associations both issued formal statements pointing out that delays in designating notified bodies are the biggest barrier to products being able to comply with the new EU Medical Device Regulation before deadlines. Time is running out.