MHRA Releases Suite of Guidance for New Post-Market Surveillance Regulation

By Amelia Boldrick and Elizabeth Pugh

The Medicines and Healthcare products Regulatory Agency (MHRA) announced the release of a suite of post-market surveillance (PMS) guidance (January 15) in alignment with The Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2024.

Background

As Emergo by UL reported last month, the amendment introduces new and enhanced PMS requirements for manufacturers that supply medical devices in Great Britain (GB). Additional regulatory updates were posted to the Emergo by UL website comparing the new PMS requirements between GB and EU in terms of vigilance and PMS. Manufacturers are encouraged to review the new guidance well in advance of when the statutory instrument comes into force, June 16.

Summary of topics addressed by guidance

The new suite of guidance includes a primary consolidated resource for implementation of the new PMS requirements and additional specialized resources on PMS and vigilance reporting.

Device-specific vigilance guidance updates

The MHRA has also published updates to their device specific vigilance guidance (DSVG) for the following product types, noting that these should be reviewed in tandem with the new PMS guidance:

Although the MHRA and European Union (EU) Medical Device Coordination Group DSVG resources are similar in content, they are not identical and the devices they cover currently differ. The U.K. has also historically offered DSVG for more types of devices than originally covered by the EU DSVG (MEDDEVs).

It is not yet clear whether MHRA intends to update other previously published DSVG and add to the PMS guidance landing page. For example, at the time of this update, the DSVG for biological and mechanical surgical heart valves has not been updated.

Concluding remarks

The alignment of PMS requirements in GB with the EU corrects an unintended consequence of Brexit and marks an important regulatory convergence between the two markets. However, small but important differences, such as the requirement to notify MHRA of overseas FSCAs whether or not GB is affected, prevent harmonization.

We anticipate publication of new vigilance report forms for GB in the near future. The long-awaited EU MDR vigilance report forms may be released at any moment and will not include GB among the list of countries available for selection when indicating where a device is supplied.