Gary Baker, Medical Devices Director at Squirrel Medical, discusses the new post-market surveillance regulations for UKCA- and CE-marked medical devices, requiring manufacturers, dealers, and distributors to actively monitor, report, and respond to real-world safety and performance issues to enhance patient protection and support safer, faster innovation.
On 16 June 2025, Great Britain entered a new era of medical device oversight. The Medicines and Healthcare products Regulatory Agency (MHRA) has implemented its first major overhaul of post-market surveillance (PMS) regulations — a change that reshapes how medical devices are monitored once in use by patients and care providers.
This is more than a regulatory update. It is a strategic shift acknowledging that real-world use — not just pre-market testing — must guide our understanding of safety and performance across the device’s full life cycle.
The new PMS framework applies to all UKCA- and CE-marked medical devices placed on the GB market from 16 June 2025 onward. This includes diagnostic tools like glucose monitors and PSA tests, implantables such as pacemakers, and a wide range of technologies used in hospitals, clinics, and homes.
What changes for manufacturers
Manufacturers must now actively collect and assess safety and performance data from medical devices already in use. They are expected to:
- Detect trends and risks earlier
- Report serious incidents within 15 days (previously 30)
- Submit Field Safety Notices to the MHRA for review before sending them to users
- Provide PMS Reports or Periodic Safety Update Reports (PSURs) within three days of request
These changes enable faster, clearer responses to safety issues — protecting patients and healthcare workers who depend on reliable technology every day.
Devices classified as higher risk, such as class 2a active alternating mattresses and cushions, now undergo closer scrutiny. These products must be certified by a UK approved body, such as SGS, and listed clearly in a medical device certificate that includes each specific product model. This step ensures that the safety of pressure-relieving systems used in vulnerable patient care is held to the highest standard.
What this means for dealers and distributors
The new regulations also place clear responsibilities on dealers and distributors to support safety monitoring and regulatory compliance. Their role is now active—not passive.
Here’s what’s required:
- Verify product compliance
Before placing a product on the market, verify that it is UKCA- or CE-marked, includes proper documentation, and has accurate instructions and labelling.
- Support traceability
Keep accurate records of which devices were sold, to whom, and when. This is essential for rapid response in the event of a recall or safety notice.
- Report problems promptly
If you become aware of a serious incident involving a device you supply, you must inform the manufacturer immediately.
A regulatory framework that protects and enables
As Lawrence Tallon, MHRA Chief Executive, put it: “As innovation in health technologies accelerates, regulation must keep pace.”
This reform ensures that the UK’s device regulation system evolves alongside innovation, balancing patient safety with the need to bring effective technologies to the people who need them.
It was shaped by input from industry and recommendations from the Independent Medicines and Medical Devices Safety Review. The implementation guide, published in January 2025 and updated with industry feedback, offers detailed instructions for complying with these new obligations.
Final note on active alternating pressure devices
Distributors and buyers of class 2a alternating pressure mattresses and cushions must take extra care:
- Confirm they are registered with the MHRA as class 2a medical devices
- Ask for the valid medical device certificate issued by a UK approved body, listing each specific mattress or cushion model
These steps are not just regulatory—they are essential for patient protection in high-dependency care settings.
This regulatory reform is a defining moment for the UK medical technology sector. It sets a higher bar for safety, accountability, and trust — while also building the infrastructure for faster, safer innovation.
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