UK · MHRA · UKCA
Clinical investigations in the UK, post-Brexit.
The UK is now its own regulatory market: UK MDR 2002, MHRA, UKCA marking, REC and HRA. Understand the framework, the approvals, and where UK requirements have diverged from EU MDR.
European Champion
Platinum Award 2026
Eclevar MedTech & Milo Health · xShare × EUCROF Open Call
Led by authority
UK studies, run by people who know the MHRA route.
The UK diverged from the EU. Our clinical and regulatory specialists run investigations to MHRA and REC expectations, not by assuming EU alignment.
Dr Mark DaCosta
Cardiac surgeon and former Notified Body reviewer; UK and EU device programmes across specialties.
in LinkedIn
Charline Petitdemange
Study start-up and site monitoring across the UK and Europe, including REC and HRA submissions.
Awards, funding, accountability
Europe’s best-rated medical device CRO.
Platinum Award 2026
Top tier at the xShare × EUCROF Open Call, awarded to Eclevar MedTech and its Milo Health platform, presented at EUCROF 2026 in Amsterdam.
The announcement →Co-funded by the European Union
Selected through the xShare Open Call for clinical research innovation, Horizon Europe.
xShare results →Independently reported
Distinction confirmed by an independent third party, the CVBF, also an awardee of the xShare × EUCROF Open Call.
CVBF coverage →The framework
From the UK rulebook to a compliant study.
Following the UK’s departure from the EU, conducting device clinical investigations in the United Kingdom requires compliance with UK-specific regulations. This guide walks through the framework, the approvals and the practical differences.
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The UK regulatory framework
The core documents you work to:
Key regulations & guidance
- UK Medical Device Regulations 2002 (as amended) — the primary legislation, including clinical investigation requirements
- MHRA guidance on clinical investigations — detailed requirements and expectations
- Good Clinical Practice — ISO 14155 and ICH-GCP E6
- REC — UK Research Ethics Committee approval for studies in human subjects
- HRA guidance — research governance and ethics
02 / 06
Post-Brexit changes and UKCA marking
Brexit reshaped the landscape. UK devices now require UKCA marking instead of CE marking, with conformity assessment by UK Approved Bodies and a separate UK assessment process. Transition arrangements apply to existing CE-marked devices, but the direction of travel is a distinct UK regime.
03 / 06
Regulatory divergence from EU MDR
UK regulations are no longer automatically aligned with EU MDR. In practice that can mean a separate UK clinical data package, UK-specific PMCF requirements, and an independent UK regulatory assessment. Assuming EU data transfers wholesale to the UK is where programmes get caught out.
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The approvals you need
A compliant UK investigation typically requires:
Before first patient
- MHRA notification and approval
- Favourable opinion from a UK Research Ethics Committee (REC)
- Compliance with UK GDPR for data protection
- UK-specific insurance and indemnity
05 / 06
What counts as a clinical investigation
Under UK regulations, a clinical investigation is any systematic investigation or study in human subjects to evaluate the clinical performance and/or safety of a medical device. That definition sets the trigger for MHRA and REC approval, so scoping it correctly at the design stage avoids surprises later.
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Running UK and EU together
Most manufacturers need both markets. We design programmes that satisfy the MHRA and a Notified Body in parallel, reusing data where the regimes align and building the UK-specific evidence where they diverge. See how we handle the US corridor and the German route the same way.
The UK at a glance
A separate market, on purpose.
Talk to a specialist
Planning a UK clinical investigation?
Book a free scoping call. We handle MHRA notification, REC ethics, UKCA strategy and the UK-specific data you need, in parallel with your EU programme.
Book a free scoping callUK approval is not a copy-paste of your EU file.
An expert read tells you what MHRA and a UK REC will expect, where the UK has diverged from EU MDR, and how to build the UK-specific evidence without duplicating the whole programme.
Book a free scoping callQuestions we hear first