In the recently updated guidance issued by the MHRA (Medicines and Healthcare products Regulatory Agency) — „Clinical investigations of medical devices – guidance for manufacturers“ (October 2025) — a noteworthy passage appears:
„For studies in Great Britain only, there is presently no requirement for manufacturers to appoint a UKRP – however, one may be appointed if the manufacturer wishes. For studies with sites in Northern Ireland, in certain circumstances a representative may need to be appointed in Northern Ireland or the EU.“
This clarification comes at a time when the regulatory landscape surrounding clinical investigations of medical devices in the United Kingdom is increasingly dynamic — particularly in the wake of post-Brexit regulatory developments.
Background: Regulation 103(2) SI 2019/791 and Its Evolution
Before Brexit, Regulation 103(2) of the Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (SI 2019/791) required that a foreign manufacturer (sponsor) of a clinical investigation in Great Britain appoint a representative if established outside the UK.
With the revised MHRA guidance and its new practical provisions, the agency has now confirmed that this requirement no longer applies when a study takes place exclusively in Great Britain (England, Wales, Scotland).
In other words: a company based outside the UK no longer needs to appoint a UK representative — provided no study sites are located in Northern Ireland.
What This Means for Studies Conducted in Great Britain
- Requirement lifted: For clinical investigations conducted solely within Great Britain, the previously assumed obligation to appoint a legal representative or UK Responsible Person (UKRP) no longer applies.
- Voluntary appointment still possible: The MHRA allows manufacturers to voluntarily appoint a UKRP or representative, e.g. as an additional point of contact or for legal clarity.
- Caution for Northern Ireland: As soon as study sites in Northern Ireland are involved, a representative may still be required — either in Northern Ireland or within the EU, depending on the specific setup and scope of the investigation.
Significance & Outlook
This update gives sponsors of medical device studies greater flexibility and reduces regulatory barriers in the UK. Smaller or medium-sized manufacturers, in particular, who have so far been hesitant to plan UK-based clinical investigations, are likely to benefit from this change.
Nevertheless, some caution remains advisable:
- Studies involving sites outside Great Britain or including Northern Ireland remain subject to more complex regulatory obligations.
- For each study, an early regulatory assessment should be undertaken to determine whether — and where — representation requirements apply.
Are you planning a clinical investigation in the UK or elsewhere in Europe and need guidance on regulatory requirements or submission procedures? Get in touch with us — we’ll be happy to assist.