How to run a medical device clinical trial in the UK.

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The requirements to run a clinical trial in the UK

The United Kingdom is the one major European market that no longer runs on the EU MDR. Since Brexit, a device clinical investigation in Great Britain, meaning England, Wales and Scotland, is governed by the UK Medical Devices Regulations 2002, SI 2002/618 as amended, overseen by the MHRA. Northern Ireland continues to follow the EU MDR under the Windsor framework, so a study with sites in both is submitted to the MHRA under the EU MDR, and one application covers both.

That divergence is the first thing a sponsor has to get right. The UK runs 296 device studies over a three year window, third in Europe, and reaching that base means clearing the MHRA, a research ethics committee through the national system, and the NHS, each on its own terms. Designing that in from the protocol is the working habit of a team that runs the UK from inside it, not from a desk abroad.

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The MHRA and the post-Brexit framework

The MHRA, the Medicines and Healthcare products Regulatory Agency, is the competent authority for a device clinical investigation in Great Britain. You must notify the MHRA at least 60 days before the first patient for a device not already UKCA or CE marked for the use under investigation, through the national portal. The MHRA confirms a valid application within 5 working days, and day one of the statutory 60-day assessment is that validation date.

Devices are grouped for assessment: group A for Class I, IIa and IIb other than implantable or long-term invasive, and group B for Class IIb implantable, Class III and active implantable. A very common reason the MHRA objects is simply that the data needed was not supplied inside the statutory window. A CRO whose regulatory people have reviewed devices for a Notified Body builds the file for the reviewer who will read it.

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Ethics, the HRA and the combined review

Ethics review in the UK is run by a Research Ethics Committee under the Health Research Authority, applied for through the national IRAS system, the Integrated Research Application System. For device studies the MHRA and the ethics review run as a coordinated process through the same submission gateway, not as two disconnected filings.

The REC reviews participant protection: the information and consent documents, the risk to participants, the indemnity and the competence of the investigators. A UK team manages both so that a query on one side does not stall the other, and builds each to clear on the first pass, which is where reviewing experience from inside a Notified Body quietly earns its place.

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The timeline and the cost, against France and Germany

The UK route is a notification with a defined clock, and unlike France it carries a fee. The MHRA confirms validity in five working days, then runs a statutory sixty-day assessment, and charges for it. The trade sits between France and Germany: more expensive than free France, broadly comparable to Germany, and on a single national timeline rather than a sequential one.

The MHRA charges a fee for each clinical investigation notification in the order of 5,100 pounds, scaled by device group, increased in July 2025, with a fee waiver only for innovative devices from UK based small companies. Filing through IRAS and answering the MHRA inside the statutory window is the execution that turns a defined timeline into a kept one.

Route and cost positions reflect public regulator guidance current at the time of writing; the MHRA updates fees periodically, so confirm current figures for your study.

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The budget: insurance, NHS site costs and the NIHR

The budget of a UK study turns on the device risk, which sets the insurance and indemnity cover, and on where the study runs, because UK sites mean the NHS. Insurance and indemnity are mandatory and scale with the risk the device carries; the mistake is to budget them flat rather than to the risk and the procedures the study adds.

The UK leads Europe in the fields at the centre of Eclevar cardiovascular franchise. A UK CRO that knows these centres and their investigators turns the depth into site access and a realistic budget. Eclevar names the specific sites and investigators it would propose under confidentiality, matched to the device and therapeutic area, not on a public page.

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UK GDPR and the Data Protection Act

Clinical data in the UK is personal health data under the UK GDPR and the Data Protection Act 2018, with the more recent Data (Use and Access) Act 2025 bringing further provisions for scientific research and international data transfers. Since Brexit the UK runs its own data regime, aligned with but legally distinct from the EU GDPR, so the basis cannot simply be copied from an EU protocol.

The data protection basis, the patient information, the consent and the data flows have to be defined for the UK before enrolment, including the position on transfers to and from the EU. The CRO has to run its data capture and management, on the MILO platform, built to satisfy the UK GDPR and 21 CFR Part 11 together, with a named data protection officer in the chain.

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The quality system your CRO must hold

Whether your study supports a UKCA mark, a CE mark or both, you remain accountable for outsourced clinical work, which makes your CRO a critical supplier inside your own quality system. The CRO should hold an ISO 13485:2016 certified quality management system, run investigations to BS EN ISO 14155:2026, and validate its data systems to 21 CFR Part 11.

BS EN ISO 14155:2026 sets clinical quality management in section 9.1 and risk-based monitoring in section 6.7, and the MHRA expects investigations conducted to it. A CRO that holds the ISO 13485 certification in its own name, rather than working under a sponsor, is the one that can stand behind the chain when the auditor pulls it, as set out in quality and professional services.

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The NHS, the NIHR and the KOL

UK clinical research runs through the NHS, and the leading investigators and key opinion leaders sit in the NHS teaching hospitals and specialist centres. The NIHR, the National Institute for Health and Care Research, provides a national research infrastructure few countries can match, and an HRA approval governs the NHS side of a study.

Setting up an NHS site is a defined process with its own steps and timelines, from HRA approval to local capacity and capability confirmation. A team that has run the NHS research setup before moves through it far faster, and the relationship with an NHS KOL as chief investigator lifts the credibility of the whole study.

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Investigator initiated studies, and when they win

In an investigator initiated study the sponsor is an investigator or an academic institution, an NHS trust or a university, not the device manufacturer. The UK has one of the strongest academic research ecosystems in the world, and the NIHR funds non-commercial studies a manufacturer sponsored study cannot access, which makes the route especially viable here.

The trade-off is that the manufacturer gives up control of the protocol, the timeline and the data ownership. That is wrong for a pivotal pre-market study a manufacturer needs to own, and right when independence, cost and credibility matter more than control. Eclevar both advises manufacturers on the choice and runs the operations behind an investigator initiated study so it still meets BS EN ISO 14155.

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Why you still need a UK team

Brexit did not remove the need for a UK presence, it sharpened it. Submissions run through IRAS, NHS sites are set up through the HRA and local NHS research offices, and the UK data regime is now its own. A CRO coordinating the UK from the EU, as if it were still one MDR market, is working against the grain of a system that has deliberately diverged.

A UK based team is what files correctly through IRAS, navigates the NHS research setup and holds the relationships that move a study. Regulatory people who know the UK MDR 2002 and the MHRA, and a clinical team who know the NHS, are the difference between a study that moves and one that stalls.

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First in human versus PMCF in the UK

A first in human or early feasibility study, with a device not yet UKCA or CE marked for the use under investigation, requires a full MHRA notification and the 60-day assessment, with the highest scrutiny on the risk analysis and preclinical justification.

A post-market study on a device already UKCA, CE or CE UKNI marked and used within its intended purpose may not require an MHRA notification at all, a point the MHRA clarified in its 2025 guidance, so many post-market follow-up or usability studies carry a lighter load. Reading which route governs before the protocol is written is a judgement a senior clinical team makes, not a box a generalist ticks.

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What the CRO must be equipped with

A CRO that can run a UK study has to be equipped on every axis: a UK footing, a regulatory function that files through IRAS to the MHRA and the ethics committee and knows the UK MDR 2002, a clinical team that sets up and monitors NHS sites, an EDC validated to 21 CFR Part 11 and compliant with the UK GDPR, in-house biostatistics and medical writing, and a quality system that holds it together.

Eclevar runs this stack in house: regulatory affairs, clinical operations and monitoring, biostatistics, data management on the MILO platform, medical writing and an ISO 13485 quality system, with PMCF and Notified Body engagement on the same team. No link is outsourced to a vendor you cannot see, because every link is one the Approved Body or Notified Body will eventually inspect.

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Criteria to select a UK CRO

When you choose a UK CRO, the criteria are checkable. Does it have a UK footing and people who know the UK MDR 2002 and the NHS, or does it coordinate from the EU? Has it taken devices through the MHRA and a research ethics committee, and can it name the studies? Does it hold an ISO 13485 quality system and run to BS EN ISO 14155? Can it explain the UKCA, CE and Northern Ireland positions without prompting?

Eclevar answers each with evidence: a clinical leadership with NHS experience, the 666 patient Meril TAVI study run in the United Kingdom, an ISO 13485 quality system, and a former Notified Body reviewer leading cardiovascular regulatory work. The same logic, in full, sits in the guide to selecting a medical device CRO in Europe.

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Specific by therapeutic area, never generalist

The last criterion is the one most sponsors underweight: a UK CRO has to be specific by therapeutic area, not generalist. An ablation catheter, a structural heart implant, an orthopaedic implant and a software as a medical device do not share endpoints, investigators, NHS centres, standards or assessor expectations. A generalist that runs them all the same way satisfies none of them deeply.

Take structural heart, the field where Eclevar ran its UK study. TAVI has now treated more than 1.5 million patients worldwide, and the 2021 ESC and EACTS guidelines place it as a Class I, Level A option for patients aged 75 and over. That sets the comparator and endpoints a structural heart study has to reflect, and it differs entirely from an ablation or orthopaedic study. Eclevar is built as therapeutic franchises, each led by a clinician of that field.