The UK MHRA’s June 2025 updates introduce sweeping changes to post-market surveillance requirements for medical devices in Great Britain, marking the first major regulatory shift since Brexit. With new PMS regulations now in force, manufacturers must urgently update surveillance systems, incident reporting protocols, and FSCA procedures to stay compliant and maintain market access.
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) published several critical updates in June 2025 that significantly reshape the post-market surveillance (PMS) requirements for medical devices in Great Britain. These changes mark the first major regulatory overhaul since Brexit and signal tighter compliance expectations.
The MHRA has updated its guidance for medical device manufacturers on post-market surveillance (PMS), adverse incident reporting, and field safety corrective actions (FSCA). The guidance has been updated to reflect the coming into force of The Medical Devices (Post-market Surveillance requirements) (Amendment) Regulations 2024 and add for 'Documentation for implementation of data requirements under the new Post-Marketing Surveillance regulations'.
The MHRA has published new and updated guidance to support the upcoming UK Post-Market Surveillance (PMS) regulation. The UK PMS Requirements: Statutory Instrument (SI) 2024/1368 came into force on 16 June 2025 and will apply six months after this date.
The MHRA also released an explainer video and detailed guidance to help manufacturers comply with the new requirements.
This update is considered the first major overhaul of medical device regulation in Great Britain, signalling the MHRA’s intention for stricter oversight of PMS activities going forward.
The MHRA has updated its GB MIR and FSCA schema implementation guide to support manufacturers in reporting Manufacturer Incident Reports (MIR) and Field Safety Corrective Actions (FSCAs).
This update aligns with the implementation of the Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2024 and provides detailed instructions on the revised reporting process to the MHRA.
The new PMS framework will demand stronger post-market vigilance and faster reporting from manufacturers. Companies should:
Timely alignment with these UK-specific requirements is essential to maintain market access and regulatory compliance.
Learn more about MHRA UK Medical Device Registration & Approval.
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