Regulating Medical Device Software

3:25 PM - 3:55 PM

EU MDR presents a number of challenges for medical device manufacturers. With regards to software medical devices, changes to classification have been a leading cause for concern. It looks like nearly all software medical devices should be classified as IIa, IIb or even class III, where previously the majority have been class I. Current MDCG guidance introduces a pathway to potentially justifying a lower classification for some medical software systems, but the example for class I given in the guidance is very weak and opens up many possibilities for discussion.