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UK MHRA Guidance: Strengthening Post-Market Surveillance for Medical Devices

Writer's picture: Sharan MuruganSharan Murugan

On 15 January, the Medicines and Healthcare products Regulatory Agency (MHRA) released a suite of guidance outlining the new PMS regulations, which were signed into law on 16 December 2024 and will take effect on 16 June 2025. These guidances have been introduced updated guidance to reinforce the post-market surveillance (PMS) requirements for medical devices in the UK. These measures aim to ensure patient safety, promote transparency, and align with global best practices.


Key Highlights of the Guidance

  1. Enhanced Post-Market Surveillance Requirements

The updated PMS requirements are part of the UK's ongoing efforts to ensure that medical devices remain safe and effective throughout their lifecycle. Manufacturers must:

  • Implement robust PMS plans tailored to the specific risks and functionalities of their devices.

  • Monitor devices in real-world settings and promptly address any safety concerns.

  • Regularly submit Periodic Safety Update Reports (PSURs) to the MHRA, summarizing safety performance data and any corrective actions taken.

2. Vigilance Reporting Obligations

The MHRA emphasizes the importance of timely vigilance reporting to detect, assess, and mitigate risks associated with medical devices.

  • Incident Reporting: Manufacturers must report any incidents involving serious injury, death, or potential device malfunction to the MHRA within the specified timelines.

  • Field Safety Corrective Actions (FSCAs): Actions such as device recalls or updates must be promptly communicated to affected users and the MHRA.

3. Data-Driven Decision Making

Manufacturers are encouraged to leverage real-world data and user feedback to proactively identify trends that may indicate emerging risks. Advanced technologies, such as artificial intelligence and machine learning, can enhance the predictive capabilities of PMS systems.

4. Supporting Documentation

Key documents required under the new PMS framework include:

  • PMS Reports for Class I devices.

  • PSURs for higher-risk devices (Class IIa, IIb, and III).

  • Detailed records of FSCAs, device modifications, and customer communications.


These updates align with the MHRA's commitment to safeguarding public health by ensuring medical devices in the UK market continue to meet high safety and performance standards. The strengthened PMS framework reflects lessons learned from historical device failures and global regulatory harmonization efforts.


The MHRA has compiled a comprehensive collection of medical device guidance for manufacturers to assist with vigilance and PMS obligations. For further details, explore the MHRA’s full collection on Medical Devices Guidance for Manufacturers on Vigilance.

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