MHRA Introduces Stricter Post-Market Surveillance Requirements for Medical Devices
The Medicines and Healthcare products Regulatory Agency (MHRA) has published draft regulations to amend the Medical Devices Regulations 2002, introducing more stringent post-market surveillance (PMS) requirements for medical devices in the UK.
These draft regulations, laid before Parliament on 22 October 2024, aim to bring the UK’s regulatory framework closer to international best practices and improve patient safety.
The Components of the New PMS System
Under the new regulations, manufacturers will be required to maintain a PMS system for each device placed on the market or put into service in Great Britain.
This system must be appropriate and proportionate to the risk posed by the device and include detailed records on the quality, performance, and safety of the device throughout its lifetime.
The PMS system will be based on a PMS plan that outlines the device’s lifetime, including its shelf-life and the period the manufacturer expects the device to perform as intended.
The plan will also specify processes for collecting and assessing information related to the device, monitoring serious incidents, and ensuring compliance.
Enhanced Reporting and Compliance Obligations
The new regulations include enhanced reporting requirements, mandating manufacturers to report serious incidents involving their devices, any preventative actions taken, and significant increases in the frequency or severity of incidents.
Additionally, manufacturers must immediately report serious incidents to the MHRA once they establish a causal relationship between the device and the incident. This includes submitting a final report detailing any field safety corrective actions taken.
Implementation and Impact Statistics
- The regulations are expected to come into force in summer 2025, following a six-month implementation period.
- Comprehensive guidance will be published to support manufacturers in complying with the new regulations.
- The new requirements will apply to devices with both CE and UKCA markings, ensuring parity in reporting obligations.
Industry Response and Compliance
Laura Squire, MedTech Regulatory Reform Lead and Chief Officer at the MHRA, said:
“The new Post-Market surveillance regulations will provide us with more safety information on medical devices in use in GB, 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.
“Manufacturers should start using the guidance straight away so that they are ready to comply with the regulations.
“Feedback is encouraged and will help us to address additional enhancements should they be needed.”
Osborne Clarke, Expert
The introduction of these new regulations should not come as a surprise to manufacturers, as the UK regulatory framework was falling behind international PMS best practice. Manufacturers should start to prepare now by reviewing and updating their existing procedures to align with the new requirements.
Manufacturers already have PMS procedures in place to manage liability risks, and compliance with the new regulations will involve refining these existing processes.
The formalization of PMS requirements in legislation rather than guidance will provide greater certainty for manufacturers in regulatory and product liability contexts.
Progress and Future Developments
- The MHRA consulted on the “Future Regulation of Medical Devices in the UK” in 2021, which received industry support for clearer PMS requirements.
- The new regulations are part of broader reforms responding to recommendations from the Independent Medicines and Medical Devices Safety (IMMDS) review.
- These changes aim to support the development of a regulatory framework that enables transformative technologies to reach patients quickly and safely.
Local and Sector-Specific Impact
The new regulations will have a significant impact on the medical technology sector in the UK, ensuring greater oversight and patient safety. For practitioners such as pharmacists who sell medical devices, the new approach may result in fewer recalls and a stronger foundation for patient safety.
This aligns with the UK’s goal of differentiating its legislation while maintaining global alignment and improving public health.
Immediate Implications and Broader Significance
The immediate implications of these regulations include a heightened focus on continuous monitoring and reporting by manufacturers, which will lead to earlier detection of safety issues and more effective preventive actions.