Though the EU Medical Device Regulation application was postponed from May 2020 to May 2021, the decision was reached with patient health at the forefront. Meanwhile, there is no standalone regulatory route for AI-driven medical devices in Europe.
Questions have been raised around the speed of regulatory procedures due to the COVID-19 pandemic-driven desire for new AI based technology to aid the treatment of patients. Have regulatory procedures for medical devices been fast-tracked because of COVID-19?
We explain why we think the answer is no, and discuss this, plus other key points relating to AI and medical devices, on our Life Sciences microsite, On the Pulse.