Vigilance Reports in the UK: New Obligations for Manufacturers
The British Medicines and Healthcare Products Regulatory Agency (MHRA) has updated the regulation on post-market surveillance (PMS) with effect from 16 June 2025. PMS) effective 16 June 2025. The introduction of Part 4A of the UK MDR by the MHRA specifies the post-market surveillance requirements for manufacturers.
Manufacturers must prepare for more systematic surveillance requirements and tighter deadlines, which apply to both the reporting of incidents and the implementation of corrective measures. This article provides an overview of the most important changes and supplements our article "Post-market surveillance updated: New obligations for manufacturers and importers in the UK," in which we already presented the MHRA's plans.
Responsibilities and Accountabilities in Post-Market Surveillance
Post-market surveillance is also referred to as vigilance obligation in Germany: manufacturers must exercise vigilance, even or especially after they have placed their products on the market. The purpose of vigilance or post-market surveillance is to protect consumers and prevent risks to public health. However, the findings of systematic PMS can also contribute to improving the manufacturer's own products.
Legal responsibility for vigilance reports remains with the manufacturer. Although PMS tasks can be delegated to a responsible person in the United Kingdom (UK Rep) or an authorised representative in Northern Ireland, legal responsibility for correct implementation will remain with the manufacturer.
The new regulations impose even greater obligations on manufacturers in the form of more detailed data collection and shorter reporting and response times.
Furthermore, the MHRA reserves the right to request relevant product documentation and PMS data from manufacturers. Manufacturers must submit this information to the MHRA within three days of receiving such a request.
Reportable Incidents and Use Errors
At the heart of the vigilance system are reports of serious incidents, the inclusion of Field Safety Corrective Actions (FSCAs) and the documentation of notable trends.
One significant change concerns the handling of use errors: even if there has been no actual deterioration in health, there is still an obligation to report if there was a risk that this could have occurred or if such a risk cannot be reasonably ruled out. Examples of such risks would be the ergonomic weakness of a wheelchair or unclear instructions for use – in other words, all factors that make correct use difficult or that could make correct use harmful to health.
Shortened Reporting Deadlines
The MHRA has significantly shortened the deadlines for reporting incidents under the new regulations:
- If the product poses a serious public health threat, this must be reported to the MHRA within 2 calendar days.
- Death or serious adverse events must be reported within 10 calendar days.
- All other serious incidents must be reported within 15 calendar days, instead of the previous 30 days.
- If the MHRA requests information about a product or its PMS documentation, this must be provided to the MHRA within three calendar days.
Important: Manufacturers must not delay reporting simply because information is incomplete. Additional details can and should be submitted in a follow-up report.
UDI and MORE
With the new requirements, Unique Device Identification (UDI) will be mandatory in all vigilance reports, where available. This applies to both incident reports and FSCA reports. The aim is to improve traceability and enable clear identification of the devices concerned.
Incident reports must be submitted exclusively via the MORE portal. In addition to the initial report (within the specified time limits), a final report is required after the investigation has been completed. Among other things, this must contain similar incidents that have been observed, investigation results and a justification as to whether further measures are necessary or why not.
Trend- and Periodic Summary Reports
Manufacturers are obliged to monitor trends in incidents and report significant increases – even if individual cases would not normally be reportable. This places greater emphasis on continuous data analysis.
Manufacturers who have an exceptional use authorisation for certain products are required to submit Periodic Summary Reports (PSRs) to the MHRA. An exceptional use authorisation exempts the products concerned from most requirements and documentation obligations, but is only granted by the MHRA in exceptional cases. Exceptional use authorisations or agreements on PSRs granted before December 2022 are no longer valid.
Field Safety Corrective Actions (FSCA) and Field Safety Notices (FSN)
If manufacturers identify problems that could lead to a serious incident, they must initiate a Field Safety Corrective Action (FSCA). This includes recalls, software updates or changes to the instructions for use.
What is new is that the draft Field Safety Notice (FSN) must be submitted to the MHRA prior to publication. The FSN must contain UDI information, be created in a searchable format and remain publicly accessible for the entire duration of the PMS.
Special feature: Even FSCA events that take place outside the UK must be reported to the MHRA if similar devices are on the market in the UK – even if no incidents have been reported for these devices.
Summary of the most important changes
- Delegation of PMS obligations is possible, but legal responsibility remains with the manufacturer.
- Potential use errors must now be reported even if no incident has occurred.
- Reporting deadlines have been halved: 15 days instead of 30 for most serious incidents.
- UDI information is mandatory in all reports and FSNs.
- FSNs must be submitted to the MHRA in advance, created in a searchable format and made available on a long-term basis.
- Manufacturers must respond to information requests from the MHRA within three days.
What Does it all Mean?
The new MHRA guidelines significantly tighten the requirements for medical device manufacturers' vigilance systems. Shorter deadlines, the extension of reporting requirements to include user errors, and stricter transparency requirements for field safety notices necessitate early adaptation of internal processes.
Manufacturers should review their vigilance and PMS structures and, in close consultation with their UK rep or responsible person, ensure that the new obligations are reliably fulfilled.
BEO BERLIN can assist you with structural adjustments to meet the new MHRA requirements. With many years of experience as a UK representative and as a responsible person on behalf of medical device manufacturers, we can work with you in a professional partnership to find pragmatic solutions.
