Book a free 60-minute EU MDR check-up. Bring your device and your questions; we map your gaps, your fastest compliant route and where evidence is missing, with no obligation.
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, presented at the EUCROF 2026 conference in Amsterdam.
Horizon Europe · Grant Agreement No. 101136734 · Amsterdam, 2 Feb 2026
Leading device manufacturers choose Eclevar for clinical evidence and real world evidence. Read all client success stories.
Your free session is run by senior people who assessed technical files from inside Notified Bodies. Dr Mark Da Costa, COO and former TÜV SÜD reviewer, and the team read your situation the way a reviewer will, and tell you plainly what stands between you and CE marking.
Most CE-marking delays come from problems that were visible early: weak equivalence, thin PMCF, an incomplete CER or a mis-classified device. A focused hour with a former reviewer surfaces them while they are still cheap to fix.
You leave the call with a clear read of your risk class, your evidence gaps and the fastest compliant route, whether or not you work with us.
A structured, senior review of the essentials, tailored to your device.
Confirming your risk class and conformity-assessment route.
Where CER, PMCF and clinical data fall short.
A prioritized path to Notified Body ready evidence.
Eclevar deploys in-house Clinical Research Associates in the United Kingdom, Germany, France and Sweden, ensuring smooth study initiation, ethics-committee submissions (for example CPP in France) and high-quality clinical data collection.
Pick a 60-minute slot; tell us your device and indication.
A structured review with a former Notified Body reviewer.
A clear, prioritized list of what to do next.
Certainty on your risk class and pathway.
A clear map of your evidence gaps.
What to fix first, and why.
A realistic view of your route to CE marking.
Where budget will actually be needed.
Actionable advice whether or not you engage us.
Data quality means completeness, consistency and accuracy across all investigational sites.
Choose a free 60-minute slot online.
Share your device, indication and current documents.
A structured senior review of your situation.
A prioritized list of next steps.
Optional proposal for the fastest compliant route.
RegenLab needed PMCF data to renew its CE marking without disrupting clinical workflows. Eclevar designed a targeted RWE-PMCF registry study on the MILO EDC platform capturing wound-healing trajectories and adverse-event tracking.
Multicentre study with retrospective and prospective record data from French university hospitals (CHU Valenciennes, Nantes, Brest), covering carotid and femoral locations up to 3 years post-op and meeting EU MDR requirements for CE certification.
Whitepapers, client testimonials and publications produced by our teams and partners (BSI, TÜV SÜD, RegenLab).
Written with Notified Body BSI: a practical reading of the clinical evidence expectations under EU MDR 2017/745, relevant to any clinical program.
Eclevar manages RegenLab's PMCF program on chronic wound devices: a randomized study of 160 patients across 14 sites in 5 EU countries, covering both diabetic foot ulcer (DFU) and venous leg ulcer (VLU) indications. The partnership combines Eclevar's ISO 14155 clinical expertise with the Milo Studio platform to deliver post-market clinical follow-up evidence that supports both Notified Body scrutiny and reimbursement endpoints.
« Eclevar, with its tailor-made approach and advanced Milo Studio platform, represents a major strategic asset. »
Yes. The 60-minute EU MDR check-up is free and carries no obligation.
Senior people who assessed technical files from inside Notified Bodies, including a former TÜV SÜD reviewer.
Your device, its intended purpose and any existing documents (draft CER, classification, test reports).
A clear read of your risk class, your evidence gaps and the fastest compliant route, plus a prioritized action list.
No. The advice is actionable whether or not you decide to work with Eclevar.
Tell us your device and indication; a former Notified Body reviewer will map your fastest compliant route in 60 minutes, no obligation.
Book a free call