Enhanced PMS requirements come into force for ALL medical devices in Great Britain. Manufacturers must implement clearer, risk-proportionate surveillance systems with enhanced data collection, performance reporting across device lifecycle, and shorter serious incident reporting timeframes. Applies to both UKCA-marked and CE-marked devices accepted in GB market.
UK MHRA · January 15, 2024
UK Post-Market Surveillance Regulations
Enhanced post-market surveillance requirements for all medical devices in Great Britain, including risk-proportionate systems, enhanced data collection, and shorter serious incident reporting timeframes.
Implementation Date
June 16, 2025
Published by UK MHRA. HealthSignal links to the original document; the summary above is extracted from the source text.