Medicines and Healthcare Products Regulatory Agency (MHRA) finalized the Post-Market Surveillance Statutory Instrument (PMS SI), which marks a pivotal change in the regulatory framework for medical device manufacturers. This legislation, officially named the Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2024 (SI 2024 No. 1368), introduces enhanced Post-Market Surveillance (PMS) and vigilance provisions, aligning Great Britain’s regulatory practices more closely with the European Union’s Medical Device Regulation (MDR) and In Vitro Diagnostic Devices Regulation (IVDR).
Background: Development of the PMS SI
Following Brexit, the UK sought to establish a distinct regulatory system for medical devices, independent of the EU’s MDR and IVDR. The necessity for updated PMS regulations in Great Britain arose from the need for a framework that would ensure the safety and performance of medical devices post-market. The draft PMS SI was first published on July 26, 2023, with subsequent revisions after feedback and discussions, including input through the World Trade Organization (WTO) framework. On October 22, 2024, the MHRA published the final version of the PMS SI, which was formally enacted on December 16, 2024. These regulations are set to come into effect on June 16, 2025.
The PMS SI aims to provide clear guidelines for manufacturers to ensure ongoing compliance with strict post-market surveillance requirements, contributing to device safety and patient protection. While the final regulations align largely with the EU framework, several key differences require attention. This paper highlights these differences, helping UK manufacturers better understand the regulatory environment.
Key Provisions of the Final PMS SI
The PMS SI introduces several essential aspects related to post-market surveillance:
1. PMS System Structure:
The UK’s PMS system is structured similarly to the EU’s, comprising the following components:
2. Vigilance Requirements:
The vigilance requirements for reporting adverse events and Field Safety Corrective Actions (FSCAs) largely align with the EU’s, but there are key distinctions in how UK manufacturers must manage these processes.
3. Device Categorization:
The PMS SI acknowledges the categorization of devices, with enhanced surveillance provisions for high-risk devices, such as Class III and implantable devices.
Newly Introduced Concepts
- Lifetime of a Device: The expected duration of a device’s performance, which includes its shelf life.
- Risk Analysis Requirements: Manufacturers must conduct a thorough risk analysis to ensure compliance with safety and performance standards.
- Manufacturer Responsibilities: Manufacturers must maintain PMS records for specific periods—15 years for implantable devices and 10 years for all other devices. In the event of safety concerns, manufacturers must submit a Field Safety Notice and take corrective actions as needed.
PSUR Specifics
For similar devices covered by the same clinical evaluation or performance report, manufacturers may submit a single PSUR. The submission timeline and process align closely with EU regulations, although additional UK-specific documentation requirements apply.
Comparison Between GB and EU PMS Requirements
While the PMS SI shares many similarities with the EU MDR and IVDR, there are some notable differences that UK manufacturers should be aware of:
- PMS Report Timeline:
In Great Britain, manufacturers must submit the PMS Report (PMSR) within three years of a device’s market entry, with updates required at least every three years. The EU, however, does not prescribe a strict timeline for the initial PMSR submission. - PSUR Structure:
The UK mandates PSUR submissions within one year for high-risk devices and two years for Class IIa devices aftermarket placement. EU regulations are similar, though they offer more flexibility on whether a PSUR is required for devices that are not classified as high-risk. - Field Safety Corrective Actions (FSCA):
The UK introduces more detailed processes for managing FSCAs, including additional steps for notification and reporting, compared to EU regulations. - Patient and Public Engagement:
The UK PMS Plan mandates manufacturers to consider user experience, incorporating patient and public engagement into the post-market surveillance process. This aspect is encouraged in EU guidance but is not explicitly required by EU regulations.
Implications for Medical Device Manufacturers in the UK: As the PMS SI comes into force on June 16, 2025, UK medical device manufacturers must take specific steps to ensure compliance with the new regulations:
- Review and Update PMS Plans:
Manufacturers should update their PMS plans to incorporate mechanisms for post-market surveillance, considering user experience and public engagement where relevant. - Prepare for PSUR Submissions:
Manufacturers must be prepared to submit PSURs according to the established timelines, particularly for higher-risk devices. - Strengthen Vigilance Processes:
UK manufacturers need to ensure that their vigilance processes comply with the new reporting and corrective action requirements. - Establish Record Retention Procedures:
Manufacturers must establish processes to retain PMS records for the required periods—15 years for implantable devices and 10 years for others.
Conclusion
The introduction of the PMS SI represents a major step forward in the UK’s efforts to align its medical device regulatory framework with international standards while introducing specific provisions designed to enhance public health safety. As the regulations come into effect in June 2025, it is crucial for manufacturers to prepare by updating their post-market surveillance processes to comply with the new requirements. By doing so, they will not only ensure legal compliance but also contribute to the safety and efficacy of medical devices available to the public.
