As of 16 June 2025, the UK has officially implemented a new regulatory framework for Post-Market Surveillance of medical devices introducing a significant shift in how MedTech manufacturers are required to monitor and report on the safety and performance of their portfolio.
Evnia has prepared a tabular overview of the applicable requirements per manufacturer, UKRP and Approved Body.
As always, we are here to help with your regulatory journey in the GB market.
Remember!
The updated PMS requirements apply to all CE-marked and UKCA-marked medical devices in the GB market, including in-vitro diagnostics and active implantable devices.
These requirements apply to medical devices placed on the market or put into service in GB from 16 June 2025 onwards, regardless of certification.
❌ Devices to which the PMS regulations 𝗱𝗼 𝗻𝗼𝘁 𝗮𝗽𝗽𝗹𝘆
❌ Devices subject to clinical investigation or performance study
❌ Devices that have a valid exceptional use authorisation in GB
❌ Discontinued devices
❌ Devices manufactured in house
❌ Devices placed on the market or put into service up to and including 16 June 2025
❌Northern Ireland
Medical devices placed on the market or put into service in Northern Ireland (NI) must follow the MDR and IVDR requirements.
Learn more about our UK representation services here.
