Insight · Clinical Operations · United Kingdom
Submitting a device clinical investigation in the UK means satisfying three bodies, in the right order and with the right parallelism: the MHRA, a Research Ethics Committee (REC), and, for NHS sites, the HRA. Get the sequencing wrong and the start date slips, even when every document is sound.
This page walks through the UK clinical trial submission route step by step: the three approvals, how to run them in parallel, the timing rules, fees, and how Great Britain and Northern Ireland differ.
Running a device trial in the UK means satisfying three distinct approvals rather than one, and understanding how they relate is the foundation of a realistic plan. The regulator assesses the device and the investigation, the research ethics committee protects participants, and the governance approval clears the study at the level of the health system, and each has its own remit and timeline. Treating them as a single step, or assuming one substitutes for another, is the most common source of avoidable delay.
The investigation must not begin until the MHRA has raised no objection and the relevant REC opinion is in place; no NHS site in England may start until it also has HRA Approval and confirmed local management permission. Because the REC opinion can be sought in parallel with the MHRA notification, running the two tracks together is what protects the timeline.
A fee applies to the MHRA assessment. Amendments are submitted through IRAS and do not currently attract an MHRA fee; early termination or suspension must be notified within 15 days (24 hours if on safety grounds), and a final report is due within three months of the end of the investigation.
The three UK approvals, the regulator, the ethics committee and the governance approval, run on their own timelines, and the art of a fast UK start is sequencing them so they overlap rather than queue. A sponsor who submits them in the right order, with the dependencies understood, can shorten the path to first patient considerably compared with one who treats them as a strict sequence.
The regulator's notification timeline is the anchor most sponsors plan around, and building the rest of the schedule backwards from it, while preparing the ethics and governance submissions in parallel, is what keeps the UK leg from becoming the critical path. The documentation for all three can largely be prepared together, which is the practical key to running them concurrently.
Local knowledge shortens this further. A team familiar with how the UK bodies actually operate, what they expect in a submission and where applications commonly stall, prevents the avoidable queries and resubmissions that quietly add weeks, which is where a UK-experienced partner earns its place.
The art of a fast UK start is overlapping these approvals rather than queuing them. Because much of the underlying documentation is shared, the three submissions can largely be prepared together, and sequencing them so they progress in parallel, anchored on the regulator's notification timeline, can save weeks against a strict step-by-step approach. A sponsor who maps the dependencies in advance turns three serial hurdles into a coordinated, mostly concurrent process.
A complete submission centers on the clinical investigation plan (CIP), the investigator's brochure, the device description and risk documentation, the REC application, and the relevant forms via IRAS. Where standards are only partly met, the application should justify the alternative methods used to meet the essential or general safety and performance requirements.
Documentation is where UK submissions most often stall, usually over avoidable inconsistencies between the protocol, the participant-facing materials and the regulatory dossier. The bodies expect these to align precisely, and a mismatch generates queries that cost a cycle. Preparing the document set as a coherent whole, checked for consistency before submission rather than after a query, is a large part of what keeps the UK timeline on track.
Northern Ireland remains aligned with the EU MDR. Where an investigation includes sites in both Great Britain and Northern Ireland, a single submission to the MHRA made in line with the EU MDR can cover both - and by meeting the EU MDR, the UK MDR 2002 requirements for clinical investigations are deemed satisfied. This makes the GB/NI split far less painful than it first appears, provided the submission is built correctly.
The post-Brexit regulatory geography adds a dimension sponsors cannot ignore, because Great Britain and Northern Ireland do not sit in identical positions. A study that includes sites across the UK has to account for that difference rather than assume a single uniform framework, and a team familiar with the current arrangements prevents the kind of late surprise that can disrupt activation. Local knowledge of how the UK actually operates is what turns a potentially fiddly submission into a routine one.
See how we run UK device-trial submissions and post-Brexit pathways with in-country CRAs. Eclevar runs UK device-trial submissions end to end, MHRA via IRAS, the single REC opinion and HRA Approval, sequenced in parallel to protect your start date, with CRAs at UK sites and former Notified Body reviewers on the evidenc
At least 60 days before initiating a clinical investigation of a non-UKCA/CE-marked device, via the IRAS portal. If the MHRA raises no objection within 60 days, the investigation may proceed.
One. A favourable opinion from a single REC within the UK Health Departments Research Ethics Service covers the investigation regardless of the number of sites, and can be sought in parallel with the MHRA notification.
HRA Approval (with HCRW in Wales) combines governance and legal-compliance assessment with the REC opinion for NHS sites in England and Wales; an NHS site cannot start until it has HRA Approval.
Northern Ireland aligns with the EU MDR; a single MHRA submission made under the EU MDR can cover both Great Britain and Northern Ireland sites for the same investigation.
Planning a UK device trial? We will sequence the MHRA, REC and HRA tracks so nothing waits on anything it did not have to, and your start date holds.
The people who build your evidence have sat on the other side of the table.
Tell us your sites and device. We will sequence the MHRA, REC and HRA tracks so nothing waits on anything it did not have to, and your start date holds.
Whitepapers and publications produced by our teams with our notified body partners.
Written with Notified Body BSI: a practical reading of the clinical evidence expectations under EU MDR 2017/745, the same evidence your file has to support.
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Dr Nikhil Khadabadi
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