How The EU Artificial Intelligence Regulation Will Overlap With Medical Device Regulations

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.

Artificial intelligence (agsandrew/Shutterstock.com)

The European Commission is proposing the first ever legal framework on artificial intelligence and has made it clear that its new AI regulation will impact medical devices and IVDs which make use of AI. Indeed, such products will be considered high-risk.

The proposal for an Artificial Intelligence Regulation is 108-pages long. It is accompanied by an additional nine annexes spread over...