First-in-Human Medical Device Trials in the UK

The United Kingdom (UK) draws more United States (US) device companies than any other European country in our data. This guide explains how a first-in-human (FIH) or early feasibility study (EFS) is notified in Great Britain, what the registry shows, and where Latin America fits.

What the registry shows

Our query of ClinicalTrials.gov (CT.gov) found 108 early-stage, industry-sponsored device studies with at least one site in the UK, first posted between 1 January 2021 and 28 September 2026. That ranks the UK #8 worldwide on this measure. Of these, 48 used FIH, feasibility or pilot language in the title or summary, and 10 explicitly described a first-in-human or early feasibility study. 68 were run by sponsors headquartered outside the UK, 36 of them by US-headquartered companies, and 31 also listed sites in another country. Registrations went from 56 in 2021–2023 to 52 from January 2024 to September 2026.

Method: bioaccess® analysis of the ClinicalTrials.gov (CT.gov) application programming interface (API) v2, run 28 September 2026: industry-sponsored interventional device studies first posted 1 January 2021 to 28 September 2026 (6,045). Early-stage means FIH, early feasibility, feasibility or pilot wording, or phase N/A with 50 or fewer planned participants (2,968 worldwide). Sponsor headquarters were inferred for 95% of studies. Counts are registrations, not approvals, and recent years are under-counted.

How notification works in Great Britain

Great Britain (England, Scotland and Wales) runs device investigations under the UK Medical Devices Regulations 2002 (UK MDR 2002). Northern Ireland follows European Union (EU) rules, so this section covers Great Britain only.

• 60-day notice: the manufacturer, or its UK Responsible Person, must give the Medicines and Healthcare products Regulatory Agency (MHRA) 60 days’ notice before investigational devices are supplied. The application goes through the Integrated Research Application System (IRAS). If MHRA has not objected within 60 days of formally accepting the notice, the study may go ahead. MHRA’s guidance says the clock does not stop for information requests in Great Britain, and a fee applies.
• Ethics: a favourable opinion from one Research Ethics Committee (REC) within the UK Health Departments’ Research Ethics Service is needed, however many sites take part. It can run in parallel with MHRA review. MHRA does not accept approvals from independent ethics committees.
• Health service approval: for research in the National Health Service (NHS) in England and Wales, Health Research Authority (HRA) and Health and Care Research Wales (HCRW) approval combines governance checks with the REC opinion.
• Start: a study of a device without UK Conformity Assessed (UKCA) or CE (Conformité Européenne) marking may start only when the REC has given a favourable opinion and MHRA has raised no objection.

Where the UK is strong

• US sponsor familiarity: 36 of 108 early studies (33%) were sponsored by US-headquartered companies, the highest share among the ten countries we profiled, just ahead of the Netherlands.
• A fixed clock: a 60-day decision window that does not stop for questions is easy to plan around.
• English throughout.
• Therapeutic depth: Cardiovascular (20 studies), ophthalmology (17) and kidney and urology (13) led the early-study mix.

Using data from the UK in a US submission

The US Food and Drug Administration (FDA) can accept device data from outside the United States under the Code of Federal Regulations (CFR) at 21 CFR 812.28 if the study follows good clinical practice (GCP), including independent ethics review and informed consent, the sponsor supplies the required supporting information, and FDA can validate the data, if needed by inspection. The rule covers studies begun on or after 21 February 2019. FDA recognizes the International Organization for Standardization (ISO) device GCP standard, ISO 14155:2020; check the recognition status of the 2026 edition before you plan to it. Meeting 812.28 is not clearance or approval, and FDA may still ask for US data. Confirm your plan through a pre-submission under FDA’s Q-Submission (Q-Sub) program.

How Latin America compares

The UK’s 60-day MHRA window is fixed, and London is five hours ahead of US Eastern for most of the year. Across the 15 Latin American countries we track, the same query found 132 early-stage device studies in total. 38 of them were explicitly FIH or EFS, which is 12% of the 310 such studies worldwide, and 102 (77%) had US-headquartered sponsors. The region is used mainly for US companies’ first human data.

• Time zone: Panama stays on UTC−5 (Coordinated Universal Time minus five) all year, the same as US Eastern Standard Time.
• Regulation: each Latin American country has its own national pathway. We don’t quote a single clock; country planning ranges come with each proposal.
• Ethics: bioaccess® publishes a 4–8 week median planning range for ethics review in its lead countries. This is based on our experience, not a formal study, and it is not a guarantee.
• Cost: we don’t publish per-patient figures. Compare line-item budgets, including monitoring travel and translation.
• Where we work: bioaccess® has focused on FIH studies since 2010. We lead execution in Panama, El Salvador, Chile and the Dominican Republic, with 50+ pre-qualified sites across 19 countries.

When the UK is the better fit: if your clinical advisers are NHS-based, you want English-language sites with a fixed regulatory window, or your UK market entry is near-term. If you need faster enrollment in a US-aligned time zone for a first implant, compare a Latin American site side by side.

Frequently asked questions

How long does MHRA take to review a device investigation?

MHRA has 60 days from formally accepting the notice to object. If it does not object and a Research Ethics Committee has given a favourable opinion, the study can start. MHRA says the clock does not stop for information requests in Great Britain.

Do I need a UK Responsible Person to notify MHRA?

The notice comes from the manufacturer or its UK Responsible Person. Non-UK manufacturers usually act through a UK Responsible Person.

Can ethics review run at the same time as MHRA review?

Yes. MHRA guidance says the REC opinion may be obtained in parallel. One REC opinion covers all sites.

Can data from a UK first-in-human study support an FDA submission?

Yes, if the study meets 21 CFR 812.28 (good clinical practice, independent ethics review, informed consent and supporting information) and FDA can validate the data. Acceptance is not clearance or approval.

Next step

Weighing the UK against Latin America for an FIH or EFS study? Book a call with Julio Martinez-Clark to review your device class, endpoints and FDA plan.

Sources

• GOV.UK, Clinical investigations for medical devices (MHRA)
• GOV.UK, Clinical investigations in Great Britain
• MHRA, Guidance for manufacturers on clinical investigations, October 2025 (PDF)
• 21 CFR 812.28, Acceptance of data from clinical investigations conducted outside the United States (eCFR)
• FDA, Acceptance of Data from Clinical Investigations for Medical Devices
• FDA Recognized Consensus Standards database, ISO 14155:2020 (recognition no. 2-282)
• FDA, Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program
• ClinicalTrials.gov API v2 (query run 28 Sep 2026; filter in Method note)