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 the monitoring and reporting requirements.
Browse Evnia’s new white paper to better grasp MHRA’s new rationale but also for some tabular overviews of the applicable requirements per manufacturer, UKRP and Approved Body.
Navigating MHRA’s New PMS Compliance Framework – Evnia White Paper
As always, we are here to help with your regulatory journey in the GB market.
Learn more at www.evnia-ukrp.co.uk
Remember!
The updated PMS requirements apply to all CE-marked and UKCA-market medical devices in the GB market including im vitro diagnostics and 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.
