On 11 December 2024, the MHRA published an updated roadmap for the future of the regulatory framework for medical devices in the UK, indicating that it would be delivered via four Statutory Instruments. The first of the four, being the Post-market Surveillance (“PMS”) Statutory Instrument was laid before Parliament on 21 October 2024 and debated on 28 November 2024. The Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2024 (“PMS Regulations”) was made into law on 16 December 2024 and comes into effect on 16 June 2025. As announced by the MHRA on 15 January 2025, an entire suite of guidance for the PMS Regulations is available (see here). It is expected that the remaining three Statutory Instruments, which would be the future “core” regulations, will be delivered over the course of 2025.

Changes to Post-Market Surveillance

Under the current UK Medical Devices Regulations 2002 (“UK MDR”), the provisions for PMS are high-level, only requiring that the manufacturer “undertake to institute and keep updated a post-marketing surveillance system including the provisions referred to in Annex 7 [of Council Directive 90/385/EEC relating to active implantable devices]”. The explanatory memorandum to the PMS Regulations acknowledges that because there is no detail or specificity as to the current requirements, there are inconsistent ways in which manufacturers conduct their PMS activities in compliance with the regulations, which affects the quality of adverse incident data that is reported to the MHRA, and can impact public health and patient safety. This was exemplified by the issues associated with data collection and reporting of adverse events for surgical mesh implants used in the treatment of pelvic organ prolapse and stress urinary incontinence. The government published a report in December 2022 in response to the Independent Medicines and Medical Devices Safety Review of July 2020 on how the health system in England responds to reports from patients about side effects from treatments, including the pelvic mesh. The report expressly states that action for improvement is the introduction of more stringent PMS requirements.

The PMS Regulations, thus, aims to “introduce more stringent and clearer Post-market Surveillance (PMS) requirements that are risk proportionate with improved regulatory oversight” (as stated in the explanatory memorandum).

What is “PMS”?

PMS is defined in the PMS Regulations as “activities carried out by manufacturers to proactively collect and review experience gained from devices placed on the market or put into service for the purposes of identifying any need to apply corrective or preventive actions”.

What is the scope of the regulations?

The PMS Regulations set out PMS requirements for medical devices, including in vitro diagnostic (“IVD”) devices and active implantable medical devices.

The territorial scope of the PMS Regulations is Great Britain only, as the EU medical devices regulation (“EU MDR”) and in vitro diagnostic medical devices regulation (“EU IVDR”) have applied in Northern Ireland since 26 May 2021 and 26 May 2022, respectively. Although Northern Ireland goods that carry a valid CE mark under the EU MDR or EU IVDR may continue to place such goods on the Great Britain market, manufacturers in Northern Ireland that supply medical devices to Great Britain must comply with the new PMS requirements once they come into force.

What are the general requirements under the PMS Regulations?

The PMS Regulations provides for enhanced data collection, shorter timelines for incident reporting, and clearer obligations for risk mitigation and communication to protect patients and users. The PMS Regulations requires that the manufacturer:

• maintain a PMS system for each device that is placed on the market or put into service;
• ensure that the PMS system is used throughout the “PMS period” to identify preventative actions and corrective actions, tends in incidents, options to improve the usability, performance and safety of the device, and any impact on the PMS of other devices; and
• ensure the data gathered through the PMS system is used to update the technical documentation.

Importantly, the manufacturer has various new notification and reporting requirements under the PMS Regulations, which may differ depending on the classification of the medical device. See the detailed guidance from the MHRA here: The Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2024: guidance on implementation (published on 15 January 2025). 

When must the PMS system be implemented by the manufacturer?

According to the PMS Regulations, the PMS system must be used throughout the “PMS period”, which begins on the day on which the first device of a device model is put into service by the manufacturer or placed on the market, whichever is sooner, and ends with the end of the lifetime of the last device of that device model that is put into service by the manufacturer or placed on the market, whichever is later.

The current status of CE marked devices

As an aside, CE marked medical devices remain accepted on the Great Britain market for an extended period as follows:

Note that custom-made devices that are compliant with the EU MDD or EU AIMDD can no longer be placed on the Great Britain market.

The MHRA has published a helpful infographic of the timelines for placement of CE marked devices on the Great Britain market here.

What’s next?

Stakeholders in the medical devices industry should continue to watch this space, as 2025 is set to be a year filled with regulatory milestones. Alongside updated PMS regulations, the roadmap also covers other updates planned over the next two years. Regarding pre-market requirements, the MHRA is currently analysing feedback from a consultation in relation to UKCA marking, international reliance, IVDs and assimilated EU law; the consultation ran from November 2024 until January 2025. Regarding policy development, EUA guidance is set to be published in the first quarter of this year and the IVD roadmap is due to be published later this year. Similarly, guidance relating to software as a medical device, including AI and digital mental health products can be expected over the next few months.

Authored by: Sophie Vo & Quinn Liang