Eclevar runs medical device clinical investigations across Great Britain: MHRA notification and validation, a favourable REC opinion via the HRA, IRAS submission and NHS site confirmation, then ISO 14155:2026 monitoring with in-house CRAs on the ground. Seniors run your study, not account managers.
Platinum Award 2026
Top prize in the xShare x European CRO Federation "EHDS & Clinical Research" Open Call, awarded to Eclevar MedTech and its Milo Health platform, evaluated by a jury of nine independent evaluators and presented at the EUCROF 2026 conference in Amsterdam.
Horizon Europe · Grant Agreement No. 101136734 · Amsterdam, 2 Feb 2026
Device leaders rely on Eclevar to run their UK studies and reach the EU market. Read all client success stories.
Dr Mark DaCosta, COO, cardiac surgeon and former TÜV SÜD reviewer, leads a team that runs UK medical device studies as one aligned problem across Britain and Europe. We design each investigation so its clinical evidence supports both the UKCA/GB pathway and CE marking under EU MDR 2017/745, with in-house CRAs in the United Kingdom rather than outsourced monitoring.
We open your UK medical device investigation on the statutory clock and keep it aligned with your EU MDR regulatory strategy. Feasibility and site selection are confirmed before you commit.
MHRA notification and validation on the 60-day statutory review, prepared so your submission stays on track. The MHRA average in 2025 was around 51 days.
Research Ethics Committee opinion via the HRA and HCRW, submitted through IRAS in parallel with the MHRA review.
IRAS submission and NHS site confirmation so your investigation can open at the right centres, fast.
Site initiation, on-site and remote monitoring and close-out are run by our own in-house CRAs in the United Kingdom, not outsourced. Data capture runs on the MILO Studio platform, aligned to 21 CFR Part 11 and UK GDPR.
We design the UK investigation so a single clinical dataset supports both the UKCA/GB pathway and CE marking under EU MDR 2017/745. That feeds directly into your Clinical Evaluation Report and PMCF plan.
Site selection plus three costed scenarios on live UK tariff data.
Notification and validation with a favourable REC opinion via the HRA.
IRAS submission and NHS site confirmation to open the study.
ISO 14155:2026 monitoring with in-house UK CRAs on MILO Studio.
CER, PMCF and vigilance reporting kept current for UK and EU.
A medical device clinical investigation in Great Britain runs on a 60-day statutory MHRA review, in parallel with a favourable opinion from a Research Ethics Committee. In 2025 the MHRA average was around 51 days. Eclevar prepares the notification and validation package so your review stays on track. See our technical review and regulatory services.
Yes. We design your UK medical device investigation so the same clinical evidence supports both the UKCA/GB pathway and CE marking under EU MDR 2017/745, so you avoid duplicated dossiers and repeated studies. This connects directly to UK market access.
We submit through IRAS, secure a favourable opinion from a Research Ethics Committee via the HRA and HCRW, and confirm NHS sites so your investigation can open. Eclevar manages the process end to end.
Yes. Eclevar deploys in-house CRAs in the United Kingdom, so site initiation, monitoring and close-out are handled by our own team rather than outsourced. Monitoring follows ISO 14155:2026, on-site and remote, backed by a QMS aligned to ISO 13485.
We build three costed scenarios, swift, base and conservative, using live UK site tariff data, so you can size the budget before you commit. Feasibility and site selection are confirmed up front.
Talk to our team about your device, your MHRA and REC timeline and how to design one UK investigation that serves both the UK and the EU.
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