A UK Responsible Person is not an EU authorised rep

A role Brexit created, not one it inherited

Before the UK's exit from the EU, a device placed on the Great Britain market could rely on the same EU authorised representative structure used across the rest of the bloc. The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 changed that by amending the UK Medical Devices Regulations 2002 to require any manufacturer based outside the United Kingdom to appoint a UK Responsible Person before placing a device on the Great Britain market. The role sits inside a wholly domestic statute, not a transposition of MDR Article 11 — the two obligations happen to look similar because they solve the same structural problem, not because one was copied from the other. The requirement reaches every device category the amended regulations cover, general medical devices, active implantables, and in vitro diagnostics alike, and it applies regardless of how the manufacturer's EU obligations are already satisfied elsewhere.

A term defined three times, once per part

UK MDR 2002, as amended, doesn't define “UK responsible person” once and reuse the definition throughout. The term is construed separately for each part of the regulations it governs — under regulation 19B(2) for Part II, regulation 21C(2) for Part III, and regulation 44A(2) for Part IV — each covering a different category of device. A compliance file that treats the role as a single defined term, the way MDR Article 11 defines the authorised representative once for the whole regulation, has missed that the UK version was built part by part, and a gap in one part's own cross-reference doesn't necessarily close by pointing at another part's definition.

Registered with the MHRA, not with a notified body

The UK Responsible Person's core duty is registering the manufacturer's devices with the MHRA through the agency's own Device Online Registration System, DORS, before those devices reach the Great Britain market. That's a domestic registry, run by a UK regulator, entirely separate from EUDAMED and from whatever Single Registration Number a manufacturer's EU authorised representative already carries there. A device registered in EUDAMED under its EU AR's SRN has completed an EU obligation; it hasn't touched the DORS requirement at all, and a manufacturer that assumes one registration covers both markets has confused two databases that don't share data with each other.

The same shape of duties, running under a different appointment

Once appointed by a mutually signed letter of designation, a UK Responsible Person takes on a duty list that reads like a close cousin of Article 11(3)'s own eight tasks: verifying that the declaration of conformity and technical documentation have been drawn up, confirming the appropriate conformity assessment was carried out, keeping copies available for MHRA inspection, registering the devices, and cooperating with the MHRA on preventive or corrective action. The resemblance is real, but it runs in parallel rather than in place of the EU obligation. A manufacturer selling into both Great Britain and the EU needs both appointments in force at once, each under its own letter of designation, even where the same consultancy happens to hold both roles for the same client. Ending one appointment doesn't touch the other's standing either: a manufacturer that terminates its EU authorised representative and appoints a replacement has done nothing to its UK Responsible Person's own registration, and the reverse holds just as cleanly.

Where this meets the file

A representative-tracking record needs the EU authorised representative and the UK Responsible Person carried as two distinct rows — separate letters of designation, separate registration numbers, EUDAMED's SRN against DORS's own reference — rather than one “authorised representative” field assumed to cover both markets. A cross-border representative tracker built to carry that split, alongside the launch catalog's other registration templates, is previewed there now. If your program tracks the UK and EU roles differently, the shelf takes that correction directly.