MHRA Finalizes Legislation on Post-Market Surveillance Requirements

By Elizabeth Pugh, Karen Hill and Evangeline Loh

The UK medical device regulator, the Medicines and Healthcare products Regulatory Agency (MHRA) finalized the Post-Market Surveillance statutory instrument (PMS SI) in December 2024. Medical device manufacturers doing business in the UK will want to familiarize themselves with this new regulatory requirement to remain compliant and maintain market access.

Background

The draft PMS SI was initially shared on July 26, 2023, after the publication of the draft PMS SI on the World Trade Organization (WTO) website by the UK regulator MHRA. The revised final draft was shared again on October 22.

The intent has always been to emphasize the importance of PMS, analogous to the European regulations (Medical Devices Regulation 2017/745 (MDR) and In Vitro Diagnostics Devices Regulation 2017/746 (IVDR)). However, as the UK exited during BREXIT, a legislative mechanism was needed to address this.

Final PMS SI

The final instrument is considered “made” on December 16 with the official moniker, Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2024 (SI 2024 No. 1368).

The PMS SI would “come into force 6 months after December 16”, or June 16, 2025.

What is in the final PMS SI?

Many of the additional definitions related to PMS are incorporated, though there are a few that diverge from the EU. Much of the structure of the PMS System between Great Britain (GB) and the EU is identical: PMS Plan, PMS Report (PMSR), and Periodic Safety Update Report (PSUR). The requirements of the PMS System are similar, but there are some differences, which are discussed at length in a comparison between GB and the EU. The PMS SI has specific information about how devices can be organized in a PSUR while the EU manages this in the European Medical Device Coordination Group (MDCG) guidance.  

The vigilance requirements are also generally similar between the GB and EU. The terms and timelines for the different vigilance events are now identical. The notification of a Field Safety Corrective Action (FSCA) in GB includes some additional requirements, this and other differences in vigilance are discussed at length in a comparison between GB and the EU.

Concluding remarks

Once the PMS SI comes into force in June, the general PMS (and vigilance) requirements in GB will more closely align with the EU requirements.

PMS and vigilance are pivotal elements to the successful operation of the medical device enterprise. These are new GB requirements that have been introduced to further safeguard public health and to emphasize the importance of PMS and vigilance.