MHRA issues guidance on post-market surveillance, asks for industry feedback

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has published guidance to help medtech manufacturers comply with its updated postmarket surveillance (PMS) regulation, which goes into effect this summer. The guidance was published alongside other guidances that sponsors should refer to ensure their specific product complies with the upcoming regulation.

On 15 January, MHRA published guidance broadly detailing new PMS regulations signed into law on 16 December 2024 and going into effect on 16 June 2025. The agency noted that key requirements in the guidance include enhanced data collection, shorter timelines for reporting serious incidents and summary reporting, and more explicit obligations to mitigate and communicate risks to the public.

“These new regulations are part of wider regulatory reform and will introduce clearer and more risk-proportionate PMS requirements that improve the safety of medical devices across [Great Britain] and provide certainty for manufacturers,” said MHRA.

The guidance applies to medtech products, including in vitro diagnostics (IVD) and active implantable medical devices in Great Britain (England, Wales, and Scotland); the agency applies the requirements using a risk-based approach. Products sold in Northern Ireland must continue to follow PMS requirements under the EU Medical Devices Regulation (MDR) and In Vitro Diagnostics Regulation (IVDR).

“The PMS requirements differ dependent upon the basis for the chosen conformity assessment,” the guidance notes. “Only certain requirements apply to custom-made devices in GB.”

“These requirements do not apply to devices subject to clinical investigation, performance evaluation or exceptional use authorisation in GB,” the guidance added. “They also do not apply to medical devices manufactured in-house by healthcare establishments (regardless of whether custom-made).”

MHRA published supplementary guidances alongside the broader PMS guidance detailing its thinking on maintaining medtech vigilance systems. It includes guidance on effective field safety notes (FSN) on how to communicate field safety corrective actions (FSCA) to regulators. More specifically, the agency elaborates on what it considers good traceability of medtech products, such as keeping records of the date, batch, version, and serial number of medical devices; unique device identifiers (UDI); and being able to trace the products to users and distributors.

MHRA also published supplementary guidance with examples of the kinds of incidents that manufacturers should report and how to file periodic safety update reports (PSUR) using a standardized format. Furthermore, it published device-specific vigilance guidance for products such as IVD blood glucose meters, intraocular lenses, joint replacement implants, and more.

“The new post-market surveillance regulations will provide us with more safety information on medical devices in use in [Great Britain], allowing us to act swiftly when needed to reduce potential harm,” said MHRA Chief Officer Laura Squire. “This will enable not only the MHRA, but the whole health system, to better protect patients.”

MHRA recommended that manufacturers immediately implement the requirements outlined in the guidance, even though they don’t go into effect until this summer so that they are prepared for the new regulations. The agency also asked stakeholders to provide feedback on the guidances through trade associations. It said it would consider using that feedback to update the guidances before the regulation goes into effect.

Guidance announcement

MHRA issues guidance on post-market surveillance, asks for industry feedback

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