22/07/2025
Post Market Surveillance (PMS) regulations
The UK is undergoing a transformation in its medical device regulatory framework driven by a commitment to patient safety and to support economic growth in the life sciences sector.
Following concerns about the time taken to address patient harm due to inadequate regulations, highlighted in the 2020 Independent Medicines and Medical Devices Safety Review, The Medical Devices (Post-market Surveillance requirements) (Amendment) (Great Britain) Regulations 2024 (the Post Market Surveillance (PMS) Regulations) came into effect on 16 June 2025. The updated regulations are intended to create a clearer, more robust system that not only facilitates greater traceability and enhances patient safety but also provides regulatory certainty, and supports innovation and growth within the vital UK life sciences sector.
These requirements apply to all CE-marked or UKCA-marked medical devices placed on the UK market or put into service from 16 June 2025 onwards.
Key changes
Manufacturers are now required to have and maintain a PMS system for each device placed on the market or put into service in the UK. The system must be based on a PMS Plan that defines the device’s lifetime (shelf-life plus expected performance period) and outlines processes for continuous data collection and assessment proportionate to the device’s risk.
Companies must adopt a harmonised approach to gather and assess real-world data on how their devices perform in everyday use. This includes continuously analysing relevant data throughout a device’s lifetime.
The PMS Regulations expanded the scope for incident reporting to include side effects, and reduced time for reporting serious incidents to the Medicines and Healthcare products Regulatory Agency (MHRA) from 30 to 15 days. Manufacturers are also required to implement new trend and summary reporting for both serious and non-serious incidents, enabling earlier detection of safety trends.
The MHRA clearly expects to see more initiative-taking and comprehensive monitoring, detailed recording of PMS systems and plans from MedTech manufacturers, including mandatory patient and public engagement where appropriate. While changes to regulation will require firms to update their existing procedures, the MHRA suggests that improvements to data quality serve to support manufacturers in automating and reducing analysis burdens.
Looking ahead
PMS regulations represent the first step in a series of reported amendments planned for medical device regulations. The UK Government is already preparing a second major update with new pre-market requirements expected to come into effect in 2026. It is apparent that future changes are intended to bring the UK Medical Devices Regulation into closer alignment with the EU, introducing measures such as the up-classification of Software as a Medical Device (SaMD) and implantable devices, a framework for international recognition and updated classification rules for In-Vitro Diagnostic (IVD) medical devices.
With life sciences identified as one of eight key growth sectors in the Government’s new ten-year industrial strategy and substantial investments including £520 million for life sciences manufacturing and £51 million for “Our Future Health” research, the MedTech sector is positioned as an arena for significant opportunity. Expect further policy developments in this area which echo the sentiments in the recent 10 Year Health Plan for England emphasising innovation in this area.
Staying ahead of these evolving regulatory requirements will be crucial for manufacturers wanting to access or stay in the UK MedTech market and achieve sustained growth.
Should you wish to discuss any issues relating to liability exposure, medical device regulation and commercialisation of new digital health and MedTech solutions; please contact:
Yasmin Cant
