Guidance Details EU Approach On Medtech, AI Regulation Interplay

Commission Sets Out Rules On MDAI - Medical Device Artificial Intelligence

Overlapping clinical testing requirements and decision-making around significant changes to MDAI are among the tricky subjects that the new document explains.

Cogs — Complying with different sets of regulations for the same products brings unique challenges • Source: Shutterstock

The EU has issued guidance for device manufacturers on the interplay between the EU’s Medical Device and IVD Regulations and the Artificial Intelligence Act (AIA).

The document has been jointly released by the European Commission’s Joint Artificial Intelligence Board along with its Medical Device Coordination...