MHRA to change medical device post-market surveillance requirements

While emerging health tech innovations — including (notably) medical devices — could be set to completely transform the future of healthcare, the medicines and healthcare products regulatory agency (MHRA) is proposing legislative changes to ensure that new technologies are as safe as possible before hitting the UK market.

Here, specialist regulatory compliance lawyer Claire Burrows and practising pharmacist Thorrun Govind outline what you need to know about the proposed changes and their purported benefits.

What are the changes to legislation around medical devices?

• Data collection methods — as part of a post-market surveillance system (PMS), there are new explicit requirements that must be adhered to, including the methods for collecting PMS data to support improved data capture and consistency across manufacturers.
• Incident reporting — there are further obligations for manufacturers to report serious incidents, allowing safety issues to be identified more quickly.
• FSCA — manufacturers need to consider carrying out a field safety corrective action (FSCA) to prevent or reduce the risk of further serious incidents.
• Periodic reviews — PMS data should be reviewed periodically to identify trends and indications that a device might not be safe.

What is happening and when?

In 2021, the MHRA consulted on the ‘Future Regulation of Medical Devices in the UK’ in response to the Independent Medicines and Medical Devices Safety (IMMDS) review published in 2020.

The responses from the consultation show clear support for the introduction of more robust post-market surveillance (PMS) requirements to improve patient and public safety and demonstrate a need for closer alignment with international standards.

The MHRA confirmed that new legislation will introduce explicit, risk-proportionate requirements to improve the safety of medical devices in the UK. This will also provide clear direction for manufacturers ahead of further regulatory changes in the future.

On 21 October 2024, the draft Statutory Instrument (SI) on future PMS requirements was put before Parliament, accompanied by a comprehensive impact assessment. The expected date for the draft SI to come into force will depend on how long the parliamentary process takes, as it’ll first need to pass through both Houses of Parliament.

It’s expected that this will be presented in its final form within the next few weeks. A six-month transition period will then follow, making it likely to conclude in the summer of 2025.

What does this mean for manufacturers?

PMS requires manufacturers to monitor the safety of a medical device after it has been released on the market and — if necessary — take action to prevent or reduce the risk of an identified safety issue.

The draft PMS SI will be the new Government’s first step to update the UK’s legislation on medical devices. While this should help to ensure that the UK is more closely aligned with the EU’s current regulation of medical devices, there’s also an opportunity to develop and differentiate our legislation further due to being outside of the EU. 

The initial draft of the Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2024 (PMSR) was published in August 2023. The current provisions only include minor changes introduced by the MHRA, which should provide comfort to those who’ll be bound by the future regulations.

Benefits to expect

Since January 2021, all medical devices have to be registered with the MHRA before going to market.  This has allowed for quicker action to be taken when safety concerns arise.

The aim with the new legislation is to take these measures further by providing clear requirements that put patient safety first, allowing greater traceability of incidents and improving reporting for CE-and UKCA-marked devices that are placed on the market or put into service in the UK.

The MHRA has stressed that the new measures should further reduce safety issues by requiring manufacturers to identify and address issues much sooner and reduce the window for remedial action to be taken. It has also suggested that this will have secondary benefits such as more innovation and growth in life sciences, thanks to more data being available for manufacturers to enhance existing products.

For practitioners — such as pharmacists — who sell medical devices, the new approach may result in less recalls and set a strong foundation for patient safety before additional measures — including international reliance — are introduced.

The MHRA will publish guidance for medical device manufacturers on the new requirements before they come in. Retailers should familiarise themselves with the guidance as soon as it becomes available.

Talk to us

If you’re looking for support to bring a medical device to market or need guidance on how to ensure that your devices stay compliant, our medical device regulatory experts are here to help.

To find out more, talk to us by giving us a call on 0333 004 4488, sending us an email at hello@brabners.com or completing our contact form below.