Find here all our blog posts tagged with: Regulatory Strategy.

A quiet clinical consultation room with an ambient listening device on the desk between a clinician and patient.

Ambient Voice AI Just Crossed the Medical Device Line

MHRA guidance on ambient voice technology signals that clinical AI scribes and voice assistants are now squarely inside medical device regulation, not adjacent to it.

Two overlapping translucent regulatory frameworks depicted as intersecting glass panels above a European skyline.

Europe's AI Act and MDR Collide, and MedTech Wants a Rewrite

European MedTech is lobbying to revise how the EU AI Act and MDR/IVDR interact, and regulated buyers should build to the stricter combination now, not wait for the fix.

An hourglass on a steel table in a dim clinical corridor, sand falling, symbolizing a regulatory countdown for medical device AI.

The EU AI Act Grace Period Is a Countdown, Not a Pause

Brussels pushed high-risk AI enforcement for medical devices to 2027 and 2028, but the multi-year MDR/IVDR build-out clock is already running.