Back in 2024, the UK government enacted legislation to clarify and strengthen post‑market surveillance (PMS) requirements for medical devices in Great Britain. These measures came fully into force on 16 June 2025 and are now in active effect, enhancing the traceability of incidents and trends and enabling swifter regulatory action by the Medicines and Healthcare products Regulatory Agency (MHRA).
The updated framework is designed to improve risk management, support earlier intervention where safety concerns emerge, and ultimately strengthen patient safety across the healthcare system.
For medical device manufacturers, understanding and adhering to these requirements is not merely a compliance exercise but a core element of responsible product stewardship. This guide provides an overview of the UK medical device vigilance system, outlining reporting obligations, key regulatory changes, and practical considerations for navigating this strengthened regulatory environment.
The new regulations amend the UK Medical Devices Regulations 2002 by introducing a new Part 4A, dedicated to post‑market surveillance. These requirements apply to all medical devices placed on the market in Great Britain (England, Wales, and Scotland), including general medical devices, in vitro diagnostic (IVD) devices, and active implantable medical devices.
Medical devices placed on the market in Northern Ireland remain subject to the EU Medical Device Regulation (EU MDR) and In Vitro Diagnostic Regulation (EU IVDR).
As part of this reform, the MHRA has updated its vigilance processes to more effectively identify trends, patterns, and safety signals that may indicate emerging risks. This more proactive approach supports earlier detection of issues, improved regulatory oversight, and faster containment of safety concerns.
Under the UK vigilance system, manufacturers have defined obligations to report specific categories of safety‑related information to the MHRA. The primary reportable categories are:
Serious incidents
Field Safety Corrective Actions (FSCAs)
Adverse trends
A serious incident is any incident involving a medical device that directly or indirectly led, might have led, or might lead to:
The death of a person
The serious deterioration of a person’s state of health
A serious public health threat
For an incident to be reportable, all three of the following criteria must be met:
An event has occurred, or an issue has been identified.
The manufacturer’s device is suspected to be a contributory cause of the event.
The event resulted, or could have resulted, in death or serious deterioration in the health of a patient, user, or other person.
Incidents must be reported even if serious harm was prevented by intervention, chance, or mitigating measures. If an incident could have resulted in serious harm under slightly different circumstances, it remains reportable.
MHRA guidance is explicit: if there is doubt about whether an incident is reportable, it should be reported.
A Field Safety Corrective Action (FSCA) is any action taken by a manufacturer to reduce the risk of death or serious deterioration in health associated with a device that has already been placed on the market.
Examples of FSCAs include:
Device recalls or withdrawals
Issuing field safety notices or updated instructions for use
Software updates or device modifications
Advising additional patient monitoring or follow‑up
All FSCAs affecting devices on the GB market must be reported to the MHRA. Notification is made using the Field Safety Corrective Action Report Form (FSCARF), submitted via the MHRA’s MORE portal.
Manufacturers are required to establish systems to identify statistically significant increases in the frequency or severity of incidents involving their devices.
An adverse trend may involve incidents that are not individually classified as serious incidents but, when viewed collectively, indicate a potential deterioration in device performance or safety that could negatively impact the device’s risk‑benefit profile.
Where a significant adverse trend is identified, manufacturers must submit a trend report to the MHRA via the MORE portal, even if individual incidents within the trend have not been separately reported.
A major change introduced by the updated regulations is the shortened, legally binding timelines for initial vigilance reporting.
| Incident type | Reporting timescale |
|---|---|
| Serious public health threat | No later than 2 calendar days after the manufacturer becomes aware |
| Death or unanticipated serious deterioration in health | No later than 10 calendar days after the manufacturer becomes aware |
| All other serious incidents | No later than 15 calendar days after the manufacturer becomes aware |
These timelines apply to the initial vigilance notification. Investigations may continue after submission, with follow‑up information provided to the MHRA as it becomes available.
The reduction from the previous 30‑day reporting window underscores the need for robust internal processes to identify, assess, and escalate potential incidents without delay.
All vigilance reporting, including serious incidents, FSCAs, and adverse trend reports, must be submitted through the MHRA’s Manufacturers Online Reporting Environment (MORE) portal.
The MHRA does not accept vigilance reports via email or other channels. Manufacturers must therefore ensure that:
They are registered on the MORE portal
Relevant staff are trained in its use
Internal procedures support timely submission within required deadlines
Different report types are submitted using specific forms within MORE, depending on the nature and location of the event.
Manufacturers are responsible for investigating all reportable incidents to determine the root cause and assess whether corrective actions are required.
Where applicable, reports may be submitted via a UK Responsible Person, but regulatory responsibility remains with the manufacturer.
During an investigation, the MHRA may request additional information. Manufacturers must provide requested information within three UK working days, unless otherwise agreed.
There is no fixed statutory deadline for submitting a final investigation report. However, it must be provided as soon as possible once the investigation is complete. If investigations are prolonged, interim updates should be submitted via MORE.
Final investigation reports should include:
A description of investigation methods and conclusions
Root cause analysis
An assessment of whether an FSCA is required
Details of any corrective actions taken or planned
Consideration of similar incidents involving the same device
Cases remain open until the MHRA is satisfied that appropriate investigation and risk mitigation measures have been implemented.
The updated UK medical device vigilance requirements represent a meaningful step forward in protecting patients and strengthening regulatory oversight.
For manufacturers, compliance now demands a proactive approach to post‑market surveillance, supported by effective incident detection, timely reporting, and thorough investigation. Organisations should review and update internal procedures, ensure staff are trained on the new requirements, and make full use of MHRA guidance and resources.
By embedding vigilance into everyday quality and risk‑management activities, manufacturers can not only meet regulatory expectations but also contribute to a safer, more transparent healthcare environment.
ReferencesGOV.UK – Medical devices: post‑market surveillance requirements, GOV.UK – Vigilance reporting requirements