UK government to refresh post-market surveillance requirements for medical devices

On 22 October 2024, the draft Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2024 were laid before Parliament. These draft regulations amend the Medical Devices Regulations 2002 to impose more stringent requirements and obligations on manufacturers to undertake post-market surveillance (PMS) practices on their medical devices.

The draft regulations will be debated in Parliament and are expected to come into force in summer 2025, following a six-month implementation period. Guidance to support manufacturers complying with the new regulations will be published once the parliamentary process has been concluded and before the regulations come into force.

These regulations have been introduced ahead of the Medicines and Healthcare products Regulatory Agency (MHRA)'s plans for wider reform next year of the UK's regulation of medical devices.

The current regime requires manufacturers to maintain a PMS system, but details on how they conduct their PMS and associated obligations are covered in guidance rather than legislation. This has led to a lack of clarity and consistency as to manufacturers' obligations.

In 2021, the MHRA consulted on the "Future Regulation of Medical Devices in the UK", and the response received from industry supported introducing clearer PMS requirements to improve safety and to align with international practices. As such, these new regulations aim to provide greater detail on manufacturers' investigation and reporting duties and will help to establish a more consistent approach.

The new PMS system and plan

Under the draft regulations, manufacturers will be required to have and maintain a PMS system for each device that is placed on the market or put into service in Great Britain. This system will need to be appropriate and proportionate to the risk posed by the device. Information such as the quality, performance and safety of the device throughout its lifetime must be recorded.

There will be a requirement for manufacturers to base the PMS system on a PMS plan. The PMS plan specifies the lifetime of the device, the shelf-life plus the period the manufacturer expects the device to perform as intended, and includes processes for the collection and assessment of information in relation to the device. This includes processes to monitor and assess information on serious incidents, identify any trends in incidents, and ensure effective and appropriate processes are in place to investigate compliance. A request to review the PMS plan can be made by the MHRA and this must be provided within three working days of the request.

Preventative actions must be considered and regularly monitored by manufacturers, and such actions must be implemented as soon as possible to reduce any risks and bring the device into conformity.

Stringent requirements are proposed for manufacturers, under which they must conduct periodic reviews of their PMS data in a bid to support earlier detection of trends/signals that may have an impact on the safety of a medical device.

Reporting obligations

There will be enhanced reporting requirements which will require manufacturers to report the following to the MHRA:

• serious incidents involving their device;
• any preventative actions they have taken that fall under the definition of a field safety corrective action;
• a final report following a serious incident; and
• any significant increases in the frequency or severity of incidents involving a device (if they consider that increase could have a significant adverse impact on the required risk analysis).

A manufacturer will be required to immediately report to the MHRA any serious incidents involving its device, once the causal relationship between the device and the serious incident has been established. An investigation into the serious incident must be made reviewing the required risk analysis for the device and proposed preventative actions. A final report must be submitted by the manufacturer which will detail any appropriate field safety corrective actions.

Osborne Clarke comment

These amendments should not come as a surprise to manufacturers as the UK regulatory framework was falling behind international PMS best practice. Additionally, with the increase in new innovative health technologies, the regulations will also provide appropriate oversight in the medical technology sector to ensure patient safety.

Manufacturers will already have PMS procedures in place, not least to manage the liability risks associated with medical devices, and compliance with the new regulations should be a case of reviewing and updating existing procedures.

The fact that the regulations are to replace regulatory guidance puts PMS requirements on a more formal footing. This should provide greater certainty for manufacturers in circumstances where they are required to explain their policies and procedures to monitor the safe performance of products, whether in the context of a regulatory investigation or a product liability claim.

The proposed regulations cannot be amended by Parliament, only accepted in full or rejected, therefore manufacturers should start to prepare now. The amendments will reform the requirements placed on them to continuously monitor the safety and performance of their medical devices. Manufacturers should start to familiarise themselves with the new regulations to understand the changes and what their new obligations will be, including understanding what needs to be reported.

If you would like to discuss how the proposed regulation may affect your business, please get in touch with your usual Osborne Clarke contact, or with one of our experts listed below.