MHRA hub consolidates GB medical device PMS, MORE reporting and PSUR

MHRA’s GOV.UK collection page “Medical devices: post-market surveillance” functions as a consolidated compliance hub for manufacturers operating in Great Britain (GB). For pharmacovigilance and medical device vigilance teams, the practical change is not a single new form or template in isolation, but the regulator’s maintenance of a single index that signposts the core materials needed to run a compliant PMS system, route vigilance submissions, and prepare device periodic safety update reports (PSURs) under the Great Britain framework.

The collection is explicitly positioned for manufacturers and covers post-market surveillance (PMS), reporting adverse incidents, and reporting field safety corrective actions (FSCA) to MHRA. MHRA lists the collection as published on 26 January 2015 and last updated on 5 September 2025, indicating ongoing maintenance. Related MHRA guidance pages that the collection cross-links to have also been updated into 2026, reinforcing that teams should treat these pages as living guidance rather than static reference documents.

From an operational perspective, the collection signposts several distinct but interdependent workstreams that typically sit across PV operations, device vigilance, quality systems and regulatory intelligence. First, it links to MHRA guidance on the post-market surveillance requirements, including summary materials and a “table of key changes.” Second, it links supplementary guidance for the manufacturer vigilance system, including examples of reportable incidents and guidance relevant to field safety notices. Third, it includes guidance on the Manufacturers Online Reporting Environment (MORE), the MHRA submission route referenced for reporting. Fourth, it links to PSUR resources for devices, including a standardised PSUR format and PSUR guidance tied to the Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2024.

MHRA guidance states that the Medical Devices (Post-market Surveillance requirements) (Amendment) (Great Britain) Regulations 2024 came into force on 16 June 2025. MHRA’s “Medical devices: post-market surveillance requirements” guidance explains that these Regulations amend the UK Medical Devices Regulations 2002 by inserting a new Part 4A on PMS requirements for medical devices applying within Great Britain, including notification requirements for incidents and preventive and corrective actions. Other MHRA guidance pages referenced in the fact set similarly state the in-force date and frame the Regulations as supporting greater traceability of incidents and trends to enable MHRA to act swiftly to address safety issues.

For PV and vigilance teams, the key exposure is any organisation responsible for GB device vigilance reporting (adverse incidents and FSCA/field safety notice communications), any function relying on MORE as a submission route, and teams preparing device PSURs using MHRA-linked formats and guidance. This includes manufacturers placing medical devices on the GB market, including in vitro diagnostic (IVD) devices and active implantable medical devices, as explicitly referenced in MHRA guidance describing the scope of the PMS requirements in Great Britain.

Because this is a country compliance guide and consolidation/maintenance story, the immediate PV value is in governance: ensuring internal controlled documents point to the correct “live” regulator index and that operational staff follow the regulator’s current signposting for submissions and periodic documentation. In practice, that means vigilance procedures and training materials should reference the collection page as the authoritative route to MHRA materials for PMS systems, incident/FSCA notifications, and device PSUR resources. The same applies to inspection readiness: where organisations demonstrate that they monitor regulator guidance and keep procedures aligned, it can be helpful that a single MHRA hub is maintained and clearly scoped to the workflows that inspectors will commonly interrogate (PMS system, incident handling, corrective actions and periodic reporting).

PV Bulletin notes one minor documentation nuance highlighted in the fact set: an excerpt from the collection page truncates the in-force date (“16 J”), while other MHRA guidance pages state the date as 16 June 2025. Operationally, this reinforces the need for regulatory intelligence and quality owners to validate key compliance dates across the linked MHRA guidance pages and ensure internal trackers and training materials reflect the in-force date cited across MHRA guidance.

Next steps for teams mapped to GB device vigilance are therefore procedural and system-focused. Medical Device Vigilance Leads, supported by PV Quality and Regulatory Intelligence, should confirm that SOPs, work instructions and training link to MHRA’s “Medical devices: post-market surveillance” collection as the live index; validate operational readiness to submit adverse incident and FSCA-related reports using the MHRA-referenced MORE route; and confirm the device PSUR process uses the MHRA-linked standardised PSUR format and associated PSUR guidance tied to the Regulations 2024 framework. Given the evidence of ongoing maintenance updates, teams should also establish a quarterly monitoring cadence for the collection and related MHRA guidance pages.

Practical implication: if your GB device vigilance workflows, MORE submission steps, or PSUR templates are not explicitly aligned to the MHRA collection and the Regulations 2024 framework (in force 16 June 2025 per MHRA guidance), prioritise a documented gap-check and controlled document update, then monitor MHRA’s hub quarterly for maintenance changes relevant to case processing, CAPA linkage and inspection readiness.