On 21 October 2024, the UK Government laid before Parliament the draft statutory instrument setting out proposed new post-market surveillance (PMS) requirements for medical devices in Great Britain (the PMS SI). The PMS SI will significantly enhance the PMS requirements for manufacturers of medical devices placed on the market or put into service in Great Britain.
PMS comprises the post-market monitoring and evaluation of the safety and performance of a medical device. Currently, the medical devices legislation applicable in Great Britain contains limited, high-level requirements for a device manufacturer to operate a PMS system as part of its Quality Management System (QMS). Much of the detail on how a manufacturer should operate its PMS system, including incident reporting, is set out in guidance, primarily EU MedDev guidance 2.12/1 rev 8 and related guidance published under the old EU Directives (upon which the Great Britain medical devices regulatory framework is based). The PMS SI will introduce much more detailed obligations into UK legislation, with a view to creating greater consistency and making enforcement easier. The amendments contained in the PMS SI will bring PMS requirements in Great Britain broadly into alignment with those in the EU Medical Device Directive 2017/745 (the MDR) and the EU In Vitro Diagnostic Medical Devices Directive 2017/746 (the IVDR) (which apply in Northern Ireland).
Notably, the new PMS requirements will apply to all medical devices placed on the market in Great Britain (subject to limited exceptions), including devices CE marked under the EU regimes and made available in Great Britain under transitional arrangements.
Background to the PMS SI
The strengthening of PMS requirements for medical devices in Great Britain was one of the key recommendations of the Independent Medicines and Medical Devices Safety Review (the so called Cumberledge Review) due to the perceived failing of the regulatory framework to ensure systematic collection and evaluation of medical device safety concerns. The Medicines and Healthcare products Regulatory Agency (MHRA) consulted on proposals for new PMS requirements in 2021, and the PMS SI has been under development for some time. A draft statutory instrument was submitted to the World Trade Organisation in 2023, and the PMS SI was due to be laid before Parliament earlier this year, but has been delayed until now due to the election and change of government.
New PMS Requirements
The PMS SI will, once it comes into force, insert a new Part 4A into the UK Medical Devices Regulations 2002, which will apply new PMS requirements across general medical devices, active implantable medical devices and in vitro diagnostic (IVD) devices. Key requirements will include:
- PMS System: manufacturers must implement a PMS system for each device, which must be proportionate to the risk posed by that device. The manufacturer must set out how it will implement its PMS System in a PMS plan. The PMS SI will set out requirements regarding what the PMS system must comprise.
- Preventive and corrective actions: obligations on the manufacturer to take appropriate corrective and preventive actions to reduce risks and bring them into conformity where risks and non-conformities are identified. There are also obligations on manufacturers to notify its UK responsible person (UKRP) and UK approved body (UKAB) of the action, and where it is a field safety corrective action, the MHRA. These obligations are broadly equivalent to those under the EU MDR and IVDR.
- Serious incident reporting: the timelines for notifying the MHRA of serious incidents will now be set out in legislation, with these using the same categorisation of incidents and associated timelines as in the EU MDR/IVDR. Manufacturers are also under obligations to perform follow-up analysis and make further reports to the MHRA. While the PMS SI uses a definition of "serious incident" that is largely the same as in the EU Regulations, the PMS SI further elaborates on what would fall under one type of serious incident, namely a "serious deterioration of any persons state of health".
- Field Safety Corrective Actions (FSCA) and Field Safety Notices (FSN): these requirements largely reflect the MHRA's current practices and expectations for FSCA and FSNs, but set them out in legislation.
- Post-Market Surveillance Report (PMSR): Manufacturers of low risk devices must produce a PMSR within three years of the device being placed on the market or put into service, and at least every three years thereafter.
- Periodic Safety Update Report (PSUR): manufacturers of higher risk devices must produce PSURs, which set out a more comprehensive analysis based on the post-market experience of the device. The frequency of PSURs is determined based on the risk classification of the device. PSURs must be submitted to the UKAB (where applicable), which must take this into account in its surveillance activities.
- Trend reporting: manufacturers must also identify and report certain "significant increases" in the frequency or severity of incidents. The PMS plan must set out the methodology for identifying trends of concern.
- Obligations to retain PMS documentation: manufacturers and the UKRP should note that the PMS SI imposes different retention periods for PMS documentation compared to the EU MDR and IVDR, with the EU retention periods generally being longer. Therefore, they will need to either implement different retention periods in Great Britain or ensure all relevant documents are retained for the longer period.
The PMS SI will also introduce additional obligations on the MHRA and UKABs in relation to PMS, as well as granting further additional powers to the MHRA.
Next Steps
The PMS SI is expressed to come into force 6 months after it is finalised, so it is expected it will come into force in Summer 2025 at the earliest. This means that manufacturers must prepare to adhere to more comprehensive PMS regulations by that time, particularly given that it will be easier for the MHRA to take enforcement action for non-compliances with the legislative requirements. Manufacturers should review their contracts with any UKRPs and other operators in the supply chain to ensure they can meet their PMS obligations. UKRPs will also likely need to implement new operating procedures.
Given the similarities with the MDR / IVDR requirements, manufacturers that already have a MDR/IVDR-compliant PMS system can apply a slightly adapted version of that system in Great Britain. Manufacturers may also want to take the opportunity time to ensure their PMS system is functioning adequately under EU MDR/IVDR. The Dutch competent authority (IGJ) recently took the unusual step of issuing a note publicly calling for manufacturers to effectively implement PMS systems after it found inadequate implementation at all 13 of the manufacturers inspected in 2023 and 2024. The IGJ's note helpfully sets out key areas where it found inadequacies that are likely to be useful for all manufacturers evaluating their own PMS systems.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.
