Post-market surveillance for medical devices: a recap on the new regulations soon to be in force

On 16 December 2024, The Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2024 (Regulations) was enacted into law and set to come into force next Monday 16 June 2025. The Regulations amend the Medical Devices Regulations 2002 by clarifying and strengthening post-market surveillance (PMS) requirements for medical devices placed on the market in Great Britain after 16 June 2025.

The UK is undergoing a significant regulatory reform aimed at enhancing medical device safety and to put patients’ safety at the forefront of our healthcare system.  In addition, the reforms aim to support manufacturers and create a more robust and transparent structure for monitoring issues that emerge once a medical device is on the market. This will ensure that the UK remains an attractive market for health tech innovation.

Which medical devices do the regulations apply to?

PMS relates to the ongoing monitoring of medical devices with real-world use cases after they have entered the market in order to track performance, ensure compliance and identify any issues.

The new PMS requirements imposed by the new Regulations apply to most medical devices (including in vitro diagnostic devices and active implantable medical devices) put into service by the manufacturer, or placed on the market in England, Wales and Scotland on or after 16 June 2025.  The PMS requirements vary depending on the level of risk each device poses to patients.

The new PMS requirements do not apply to devices put into service or placed on the market before 16 June 2025.  They also do not apply to devices that are subject to clinical investigation, performance evaluation or supplied under exceptional use authorisation.

The Medicines and Healthcare products Regulatory Agency (MHRA) is responsible for regulating all medicines and medical devices in the UK by ensuring they are safe. The MHRA will enforce compliance with the new Regulations.

What are the key regulatory changes?

The overall aim of the PMS Regulations is to build transparency, prevent harm and build trust among healthcare professionals and patients. From a manufacturer’s perspective, the changes will help enable them to improve the performance of their medical devices.

The PMS system to be implemented in respect of an applicable medical device must be proportionate to the risk of the device and includes the analysis of data relevant to the quality, performance and safety throughout the lifetime of a device.  The PMS system will be based on a PMS plan which manufacturers must have.

Significant changes the PMS Regulations introduce include:

• Enhanced data collection methods – this is to facilitate usage tracking, making it easier to identify and address device failures.
• Shorter reporting timelines for serious incidents to the MHRA and in some cases to the UK approved body and the UK responsible person – This enables faster responses to potential safety concerns. Examples of incidents to report include (a) AI tools missing an abnormality leading to an incorrect, delayed or missed diagnosis or (b) a patient experiencing an allergic reaction following the use of a medical device.
• Clearer obligations for risk mitigation and communication – This is to protect patients and device users.

The MHRA has helpfully provided guidance notes to help understand the main changes that implementing the post-market surveillance regulations will introduce for medical devices and what manufacturers and other relevant persons need to do to prepare. MHRA continues to update their guidance with more updates expected next week.

Are there any differences with EU regulations?

It is worth noting that the requirements are similar to, but not identical to those in the EU. However, to streamline compliance processes, it is worth considering combining your EU and UK PMS reports into a single document. This approach can help to avoid unnecessary duplication while maintaining consistency.

The MHRA specifically requires that any data relevant to the Great Britain market is easily identifiable, such as having a separate tab in a document.

What are the risks of non-compliance?

Compliance with the Regulations is mandatory. Failure to comply can result in serious consequences including:

• Market access restrictions in Great Britain – This could negatively impact sales and patient access to important medical devices.
• Regulatory penalties – The MHRA may take enforcement action, such as requesting documents or initiating investigations. Note that PMS documentation must be provided within three working days of a request.
• Product deregistration from the MHRA device registration database – This could be catastrophic as product registration is a legal requirement for all medical devices (whether CE or UKCA). Deregistration could significantly disrupt business operations like supply chains or exposing you to legal liabilities.
• Reputational damage – This undermines trust with patients, healthcare providers and suppliers.

Next steps

If not already done so the following should be considered as soon as possible:

1. Take time to thoroughly understand your obligations under the Regulations;
2. Evaluate the organisation’s current PMS processes to check compliance and identify any actions required;
3. Provide training for your staff;
4. Develop a PMS plan to incorporate data collection, analysis and risk management strategies; and
5. Stay informed about any further regulatory developments in the quickly evolving landscape – review MHRA guidance notes and other relevant resources.

Preparation is key – organisations that act now and have been working towards the new PMS will be better positioned to maintain compliance, minimise risk to patients, and support innovation.

How we can help

If you would like help with complying with the new PMS regulations, please contact our health tech team who would be happy to discuss your requirements and see how they can help.