Great Britain’s New Medical Device Post-Market Surveillance Rules in Force Since June 2025

The Post-market Surveillance Regulations amend the Medical Devices Regulations 2002, which continue to govern devices placed on the market in Great Britain (England, Wales and Scotland). The amending instrument was made into law on 16 December 2024 and, after a six-month implementation period, came into effect on 16 June 2025. The MHRA described the change as the first major overhaul of medical device regulation across Great Britain.

The rules cover general medical devices, in vitro diagnostic devices and active implantable devices, whether they carry the UKCA mark or the CE mark. Standalone software and AI that qualify as medical devices are within scope in the same way as hardware. The MHRA enforces compliance, and non-compliance can lead to restrictions on placing products on the GB market.

The MHRA published guidance on the new requirements in January 2025 and updated it around the June start date. New GB data schemas for reporting went live in the Manufacturers Online Reporting Environment (MORE) on 16 June 2025.

Every manufacturer must now have a documented post-market surveillance system and a post-market surveillance plan for each device or device family, regardless of risk class. The requirements are proportionate to risk, and the plan is intended to drive active tracking of safety and performance once devices are in use.

Incident reporting deadlines have been shortened and tiered. Legal and consultancy summaries describe a maximum of 15 days for most serious incidents, 10 days for a death or an unanticipated serious deterioration in health, and 2 days for a serious public health threat. Sources differ on whether the 15-day period is counted in calendar or working days, so manufacturers should check the regulation text and MHRA guidance. Separate provisions require manufacturers to investigate serious incidents and submit a final report. One source notes that the period for reporting an anticipated serious deterioration in health was reduced from 30 to 15 days.

The scope of reportable events has been extended to include side effects, and trend reporting has been introduced: incidents that do not need to be reported individually must still be captured in the manufacturer’s surveillance data and reported to the MHRA under the trend reporting requirements. Manufacturers must also notify the MHRA of field safety corrective actions taken outside Great Britain where similar devices are on the GB market; one consultancy summary gives a deadline of three UK working days.

Manufacturers must prepare either a post-market surveillance report or a periodic safety update report (PSUR), depending on the device’s risk classification, with timescales set by class. The MHRA has issued a separate PSUR guidance document for approved bodies that refers to regulation 44ZM. The specific reporting frequencies for each class were not confirmed from the sources checked, and manufacturers should take them from the MHRA guidance directly.

For software and AI products, these duties mean that monitoring of real-world performance, user complaints and software defects must be built into the surveillance plan from launch. The MHRA’s AI Airlock regulatory sandbox, which received £3.6 million in multi-year funding in 2026 according to trade reporting, has examined topics such as predetermined change control plans, but these remain under development and do not change the surveillance duties now in force.

Manufacturers that market the same device in Great Britain and the EU will find the GB requirements broadly comparable to EU post-market surveillance obligations, but the reporting routes, timelines and data schemas are specific to the MHRA. Sponsors relying on CE marking for GB access must still meet the GB post-market rules. UK Responsible Persons acting for overseas manufacturers should confirm that vigilance procedures route GB reports through MORE.

The regulations are the first stage of the MHRA’s wider reform of the GB framework; further changes to pre-market requirements are expected separately. Pubrica does not provide legal advice; manufacturers should rely on the regulations and the MHRA’s published guidance.