New Post-Market Surveillance SI published to align UK with EU, subject to key differences for medical device manufacturers

The proposed text of the new Post-Market Surveillance regulations has been published, looking to bring UK PMS requirements for medical devices broadly in line with the current EU regime, subject to some key differences for manufacturers.

We summarise some of the key differences to the EU regime below. The draft PMS Regulations propose a six-month implementation period once Parliamentary processes have been concluded, meaning that they could become law in summer 2025. 

The MHRA had been due to publish the draft PMS legislation earlier this year but were delayed by the general election. As a result, the draft of the Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2024 were laid in Parliament on 21 October 2024. 

As a result of the UK’s exit from the EU, the MHRA consulted on proposed changes to the regulatory framework for medical devices in the UK. The responses to the consultation demonstrated support for proposals that would enable the MHRA to, among other plans, strengthen and increase PMS requirements to ensure better incident monitoring reporting and surveillance. The draft PMS Regulations aim to improve patient safety and increase the transparency of medical device information, enabling flexibility and proportionality of medical device regulation, while bringing UK regulations into closer alignment with international best practice.

How do the draft PMS Regulations differ from the current EU regime? 

The draft PMS Regulations move away from the previous UK regulatory regime (which was based on the old EU regime), to bring the UK PMS requirements broadly in line with the current EU regime (as set out in EU Medical Device Regulation 2017/745 (the EU MDR)) and EU In Vitro Diagnostic Medical Devices Regulation 2017/746 (the EU IVDR) (the EU Regulations)). 

However, there are some key differences between the draft PMS Regulations and the EU Regulations which will have important implications for manufacturers. These include:

• Some definitions under the draft PMS Regulations depart from the current EU Regulations, including “Incident” and “Serious Incident,” potentially capturing more types of incidents that manufacturers will need to be aware of.
• The draft PMS Regulations include a new definition of “similar device”, which was not present in the previous iteration of the UK Regulations, which diverges from the equivalent definition in the EU Regulations, “generic device group”. 
• Reporting requirements are more onerous in the draft PMS Regulations when compared to those in the EU Regulations, with Regulation 44ZH(2) of the draft PMS Regulations setting out specific requirements which manufacturers must adhere to when putting together a serious incident report. The result is that any reporting templates that manufacturers may already have in place for reporting incidents under the EU regime cannot simply be translated across. Manufacturers will need to consult the draft PMS Regulations to ensure that existing reporting templates are compliant and update them if necessary to include any additional information required by the draft PMS Regulations where needed. 
• The definition of “Corrective Action” has been expanded in the draft PMS Regulations, to mean action taken in order to either eliminate the cause of a potential or actual non-conformity of a device, or reduce any other risk posed by a device. This goes further than the previous definition (which is reflected in the EU Regulations) of “action taken by the manufacturer in order to eliminate a non-conformity”. Manufacturers should also take note of Regulation 44ZG of the draft PMS Regulations, which introduces a need to report a Corrective and Preventative Action (CAPA) to the UK Responsible Person and UK Approved Body.
• Regulation 44ZF of the draft PMS Regulations imposes a requirement on manufacturers to seek out information of the user experience in relation to safety and performance through patient and public engagement where appropriate.
• Requirements surrounding retention of PMS-related documentation have been amended, to be the longer of the lifespan of the last device of that model that is put on the market OR 10 years (15 years for implantable devices) (Regulation 44ZQ).

Some of the obligations previously proposed for the new PMS regulations have been removed, such as the requirement to publish filed safety notices on the manufacturer’s website. However, the 3-day reporting requirement remains, albeit with provision for MHRA to exercise discretion in extending this deadline where appropriate. 

What does this mean for manufacturers in practice?

The draft PMS Regulations impose new and different obligations on manufacturers of medical devices than those previously in place for medical devices on the market in Great Britain. In light of the new and developed obligations, manufacturers should review and amend PMS systems to ensure they can comply with the new requirements. 

Further guidance will be published to clarify obligations in relation to issues such as reporting requirements and real world evidence. 

While existing PMS systems, plans and reporting templates which are compliant with EU Regulations will be a valuable starting point in preparing for the PMS Regulations, manufacturers will need to review and update them to ensure compliance.

If you have any questions about regulatory compliance, please contact our Healthcare team. 

This article was written by Rory Trust, Scarlett Sullivan and Sophie Pace-Bonello.