What Led to the UK’s New Medical Device PMS Regulations?
On 16 December 2024, the UK government introduced new regulations to enhance PMS for medical devices in Great Britain (GB). These changes outlined in Statutory Instrument 2024 No. 1368, aim to build on existing regulations, addressing the gaps left by the previous Medical Device Regulations 2002 (MDR 2002). While the MDR 2002 established a broad framework for PMS, it lacked specific details on conducting PMS and fulfilling vigilance obligations. The new requirements will come into effect on 16 June 2025, requiring manufacturers to ensure compliance by that date.
Key Highlights:
1. New Regulations: The Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2024 introduce specific PMS requirements.
2. Purpose: Strengthen patient safety, enhance traceability of incidents, and improve reporting trends through clearer regulatory measures.
3. Amendment to UK MDR 2002:
o A new Part 4A has been added to define PMS obligations.
o Covers general medical devices, in vitro diagnostic (IVD) devices, and active implantable medical devices used in GB.
Key Distinction – GB vs. Northern Ireland:
• Medical devices in GB will follow these new PMS regulations.
• Devices in Northern Ireland remain subject to EU PMS requirements under existing European laws.
These changes are part of the MHRA’s broader initiative to modernize medical device regulations and ensure higher safety standards across the UK.
The MHRA has released guidance to help manufacturers navigate the new UK PMS regulations. The guidance document can be accessed through the links provided: Link.
Which device are affected by the UK PMS Regulation for Medical Devices?
The new UK PMS regulation applies to all devices put into service or placed on the GB market.
The scope of these regulations include CE marked devices, which are currently allowed on the GB market under transition provisions. PART III - UK PMS Regulations vs. EU MDR: Key Differences and Impact on CE-Marked Devices in Great Britain provides valuable insights into key requirements for these devices.
Exemptions and Expectations
Exemptions from the regulation:
o Custom-made Devices - Subject to full PMS requirements except for Field Safety Corrective Actions outside GB (44ZK), PMS Report (PMSR) (44ZL), PSUR (44ZM), Trend Reporting (44ZN)
o Procedure Pack Manufacturers - Must comply with all PMS requirements, except PMSR (44ZL) and PSUR (44ZM)
Excluded from the regulation:
o Devices intended for clinical investigations and devices with special authorization from the Secretary of State.
o Discontinued devices that are no longer placed on the GB market or put into service after 16 June 2025 (the date the regulation comes into force) remain subject to the prior PMS requirements set out in the relevant legislation and detailed in MEDDEV Vigilance Guidance documents, under 2.12 PMS.
How Do the New UK PMS Regulations for Medical Devices Improve Upon MDR 2002?
The new 2024 regulations introduce more detailed and structured requirements for PMS, addressing the gaps in the Medical Device Regulations 2002 (MDR 2002), which previously contained only high-level provisions. While MDR 2002 required manufacturers to maintain a PMS system, it lacked specific details on how PMS should be conducted and how vigilance obligations should be fulfilled—these aspects were primarily covered in guidance rather than legislation.
The updates to the UK MDRs have brought greater alignment with the EU’s Medical Devices Regulations, facilitating compliance for manufacturers operating in both markets.
What is the purpose of the PMS?
PMS is an essential system that allows manufacturers to continuously monitor and analyse data on the quality, performance, and safety of their medical devices throughout its lifecycle. It also records the manufacturer’s conclusions based on that analysis. It aims to detect trends, identify preventive or corrective actions, improve device usability, performance, and safety, and assess any impact on the PMS of other similar devices to safeguard public health. By continuously assessing device performance, PMS feeds into risk management and is used to update the technical documentation for UKCA-marked devices.
What key changes were introduced with the new UK PMS Regulation?
1. PMS plan – The foundation of the PMS system
A PMS plan is the backbone of an effective PMS system, ensuring ongoing safety and performance monitoring. It must be risk-proportionate and define the device’s lifetime as per new regulations. Key elements of a PMS plan include:
• Data collection: Gathering relevant device information from various sources.
• Analysis methods: Using indicators and threshold values for risk reassessment.
• Vigilance obligations: Define process for investigating complaints, analysing feedback which includes engaging with patients and the public.
• Incident & trend management: Identifying and responding to safety signals.
• Communication strategy: Ensuring clear information flow between manufacturers, users, and suppliers.
2. Post-market surveillance report (PMSR) for low-risk medical devices – What do you need to know
Manufacturers of low-risk medical devices (class I, Class A or B IVDs, non-Annex II IVDs) are now required to maintain a PMSR to ensure ongoing device safety and performance. This requirement applies to devices on the GB market, including CE-marked devices under transition provisions.
The PMSR must:
• Summarize key findings and conclusions from PMS data in line with the PMS plan.
• Be updated at least every three years.
• Be available to the MHRA upon request within three UK working days.
This requirement applies from the date of certification or declaration of conformity and remains in effect throughout the PMS period as newly defined in the regulations.
3. Periodic safety update report (PSUR) - What Manufacturers Need to Know
For medium and high-risk medical devices, manufacturers must create and submit a Periodic Safety Update Report (PSUR). The PSUR is similar to a PMSR but includes additional information, identified in the regulations. This applies to devices on the GB market, including CE-marked devices under transitional provisions.
Key points to note:
• A standardised PSUR format was released in January 2025 by the MHRA and can be assessed following this link: standardised format for the PSUR (Published January 2025.
• Medium-risk devices (class IIa) require a PSUR update every two years, and high-risk devices (class IIb, III, Class C or D IVDs, Annex II IVDs) must be updated annually.
• PSURs should be submitted to the Approved Body, which will review them as part of their surveillance activities. This is applicable only for UKCAS marked devices.
• For high-risk devices (class III, IIa, IIb implantable devices, List A and B IVDs), the Approved Body will issue a report, available to the manufacturer and MHRA upon request.
This requirement applies from the date of certification or from the regulation's enforcement date—16 June 2025, if the device is already on the GB market—and remains in effect throughout the PMS period, as newly defined in the regulations.
Grouping devices in the same PSUR:
Manufacturers can group devices under a single PSUR, but they must meet specific criteria:
• Devices must be covered by the same clinical evaluation report and be similar in nature, with a clear justification for grouping.
• UKCA-marked devices must also share the same Approved Body.
• A leading device in the group will determine the schedule for data collection and the PSUR update frequency for all grouped devices.
The MHRA has published PSUR guidance for Approved Bodies, which manufacturers should also consider: The Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2024: guidance on periodic safety update reports (PSUR) (regulation 44ZM) for approved bodies - GOV.UK.
4. Clarification of terms
New definitions have been introduced, including:
• 'Post-market surveillance period,'
• 'Post-market surveillance,'
• 'preventive action,'
• 'required risk analysis,'
• 'serious deterioration of any person’s state of health,'
• 'serious incident' (including side effects), and 'serious public health threat.'
Additionally, other concepts have been clarified, such as the inclusion of self-administered treatments as interventions to prevent serious deterioration in health. It has also been specified that serious deterioration in health does not need to have occurred for a use error to be reportable; the risk of it occurring is sufficient.
5. Retention of PMS-Related Documentation
• Minimum retention for manufacturer and UK responsible person:
o 15 years for implantable devices.
o 10 years for all other devices.
• However, all PMS-related documentation must be retained until the end of the PMS period, even if it exceeds these timelines.
