MHRA's new UK-specific medical device regulations enter into force, replacing current system based on EU directives. Enhanced post-market surveillance, software updates regulation, and AI-enabled device requirements. Significant UK regulatory divergence from EU MDR/IVDR. CE certificates renewed after this date may not be accepted for GB market access.
UK MHRA · January 01, 2024
UK New Medical Device Regulation Implementation
UK-specific medical device regulations enter into force, replacing EU directive framework with enhanced post-market surveillance, software update regulation, and AI-enabled device requirements.
Implementation Date
July 01, 2025
Published by UK MHRA. HealthSignal links to the original document; the summary above is extracted from the source text.