AI, MDR, and Beyond: Lessons from RAPS Lisbon

First, it is acceptable to use AI in regulatory practice; however, the expert needs to remain in the loop. This really emphasizes the importance of using AI as a tool to supplement the expert, not to replace them.

Another point that stood out was the reaction to MDR 2.0. Although it is only a draft, many organizations are scurrying in absolute panic. In my view, the emphasis should instead be on ensuring that current documents and workflows are MDR 1.0 compliant. If this is done, then regardless of what appears in the finalized version of MDR 2.0, organizations will already be on the fast track, and any transition will be much smoother.

I also found it very interesting that the EMA is creating a pilot project to support the development of ‘breakthrough’ medical devices. This is a great initiative to help fast-track the certification of innovative devices, so they can reach patients sooner.

Finally, “regulatory sandboxes” was a term that kept coming up throughout the conference. It highlights the growing openness—and need—for discussion and conversation when making regulatory decisions, and it could be a useful way to iron out grey areas before formal implementation.