On 29 July 2026, the UK’s Medicines and Healthcare products Regulatory Agency (“MHRA”) (the regulatory authority with responsibility for enforcing UK medical device rules) published new guidance on ambient voice technology-enabled products (“AVTs,” also known as ambient scribing tools) (“AVT Guidance”). The AVT Guidance is intended to clarify (and essentially
Continue Reading New UK Guidance Clarifies Medical Device Status of AI Scribes
The Medical Device Coordination Group (“MDCG”) has published a new position paper (MDCG 2022-14) acknowledging the significant and urgent lack of capacity of EU notified bodies. It acknowledges the risk that this could lead to many existing and new medical devices and in vitro diagnostic medical
Continue Reading Notified body capacity needed! MDCG proposals recognize need to increase notified body capacity to ensure device availability