
The Medicines and Healthcare Products Regulatory Agency (MHRA) has issued new guidance to assist medical device manufacturers in preparing for upcoming regulatory changes related to post-market surveillance (PMS). These changes, set to take effect across England, Scotland, and Wales on 16 June 2025, introduce significant updates aimed at enhancing the monitoring and safety of medical devices after they have entered the market.
Key Changes in the New PMS Regulations
The updated PMS regulations introduce several critical requirements for medical device manufacturers, including:
- Enhanced Data Collection: Manufacturers must implement more comprehensive data collection processes to ensure a thorough understanding of device performance and safety.
- Stricter Reporting Timelines: Serious incidents must be reported within two days if they pose a public health threat, or within 10 days for cases involving unexpected health deterioration.
- Increased Transparency and Risk Mitigation: There are clearer obligations for manufacturers to communicate risks and implement mitigation strategies to protect user safety.
According to MHRA, the revised framework aims to “introduce clearer and more risk-proportionate PMS requirements that improve the safety of medical devices across Great Britain and provide certainty for manufacturers.”
MHRA’s Perspective
Laura Squire, MHRA’s MedTech Regulatory Reform Lead and Chief Officer, emphasised the importance of the new PMS regulations, stating: “The new post-market surveillance regulations will provide us with more safety information on medical devices in use in Great Britain, allowing us to act swiftly when needed to reduce potential harm. This will enable not only the MHRA, but the whole health system, to better protect patients.”
Scope of the New Regulations
The new PMS requirements will apply to a range of medical devices, including:
In vitro diagnostic (IVD) devices
Active implantable medical devices
Other medical devices based on their risk classification
Manufacturer Obligations Under the New PMS Regulations
MHRA’s guidance outlines several obligations that manufacturers must meet to remain compliant, including:
- Post-Market Surveillance Plans: Manufacturers must establish and maintain a proportionate PMS plan for all devices placed on the market.
- Incident Reporting: Serious incidents must be reported within designated timeframes to ensure swift action.
- Record Keeping: Device records must be maintained for at least 10 years, or 15 years for implantable devices, and provided to MHRA upon request.
Squire further encouraged manufacturers to begin implementing the guidance immediately to ensure full compliance before the regulations come into force. Feedback from stakeholders is also welcomed to support future improvements.
Additional Guidance on AI-Powered Medical Devices
In a related move, MHRA published guidance in June 2024 to enhance transparency around artificial intelligence (AI) and machine learning-driven medical devices. This guidance aims to improve understanding of how data is utilised and acted upon, following the agency’s strategic AI policy paper released in April 2024.
Next Steps for Manufacturers
With the implementation date fast approaching, medical device manufacturers are advised to carefully review the MHRA’s guidance and take necessary steps to align their PMS processes with the new requirements. Proactive compliance will not only ensure regulatory adherence but also contribute to enhanced patient safety and confidence in medical devices across the UK.
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