British manufacturers spent 2025 rebuilding post-market surveillance for Great Britain. Very few of them noticed that the system they built is close to the one the EU asks for, and that the remaining distance to a CE mark is smaller than it was before that work.
The Great Britain rules require manufacturers to collect and assess real-world safety and performance data, to report serious incidents to the MHRA within 15 days, to submit field safety notices for review before they go out, and to produce a post-market surveillance report or a periodic safety update report depending on the device. Trend reporting covers incidents that would not be reported individually.
A regulatory manager reading that list against Articles 83 to 88 of the MDR will recognise most of it. The fifteen-day clock is the same as the general clock in Article 87(3). The periodic safety update report has the same name and a similar purpose to the one in Article 86. The planned, documented surveillance system is the same idea as the plan in Article 84 and Annex III.
| Element of the GB system | Position on the EU route |
|---|---|
| Post-market surveillance plan and data collection | Reusable, with the plan restructured to Annex III |
| Serious incident reporting within 15 days | Same clock, different recipient and different form |
| Trend reporting | Corresponds to the trend reporting duty in Article 88 |
| Field safety notices | Corresponds to field safety corrective actions under Article 87 |
| PSUR or post-market surveillance report | Reusable as the core of the Article 86 report |
| UK Responsible Person | Does not act in the EU; a separate authorised representative is required |
| UKCA or CE certificate held for GB | A certificate for the EU must come from a body designated under the MDR |
| Registration with the MHRA | Does not create an EU registration; EUDAMED is separate |
Great Britain currently accepts CE marked devices under transitional arrangements that run to 30 June 2028 for most devices and to 30 June 2030 for others. In February 2026 the MHRA opened a consultation on recognising CE marked devices in Great Britain on an open-ended basis rather than letting those dates expire.
If that direction holds, a certificate obtained under the MDR does double duty: it opens the European Union and it keeps the domestic market. That changes the arithmetic for a British manufacturer who has been treating CE marking as an export cost. The decision worth taking now is whether the file is ready for a notified body application, not whether the EU is worth entering.
Only if it is a separate legal person established in a Member State and it accepts the mandate under Article 11 MDR. The two roles sit in different jurisdictions and cannot be discharged from the same address.
No. A certificate for the EU market must be issued by a body designated under the MDR. This is the single most expensive assumption a British manufacturer can carry into a European project.
Nothing. Registration is national to the regime that requires it. The EU actor and device records are created separately, through the authorised representative for a manufacturer established outside the Union.
The Great Britain post-market surveillance amendment and the MHRA implementation guidance were checked at source. The MDR provisions cited on this page were checked against the EUR-Lex text.
Regulation (EU) 2017/745 (MDR) in EUR-Lex → · SI 2024/1368 on legislation.gov.uk → · MHRA guidance on the post-market surveillance requirements →Review the service scope for manufacturers established outside the Union, or start with the market entry hub to see the route end to end.
