Overlapping clinical testing requirements and decision-making around significant changes to MDAI are among the tricky subjects that the new document explains.
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...
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Notified bodies are calling for their key role, as the technical, regulatory and clinical ‘extended arm’ of regulatory authorities, to remain central to the EU medtech conformity assessment process.
The US FDA has announced its user fees for fiscal 2026, which are based on a figure of $455,000 for a PMA.
NHS England's national chief clinical information officer issued a cease and desist on unapproved ambient voice technology and AI scribes. The move caused confusion among AVT vendors and went beyond joint MHRA/NHS guidance. IMed consultant Ben Austin shares his perspective.
