CE marking is only the start. We generate the clinical and economic evidence that payers and HTA bodies require for reimbursement and market access across Europe.
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.
Dr Mark Da Costa, COO and former TÜV SÜD reviewer, leads a team that designs clinical and health-economic endpoints from the outset, so the same study convinces both the Notified Body and the payers.
A CE-marked device without reimbursement never reaches its patients. HTA bodies and payers require evidence of clinical benefit and cost-effectiveness versus the standard of care.
We plan evidence generation so that clinical endpoints and health-economic data are collected together, instead of repeating expensive studies.
We align the evidence to the requirements of the national HTA bodies.
Benefit assessment and the requirements of the G-BA and IQWiG.
Assessment by the Haute Autorité de Santé (CNEDiMTS).
NICE assessment and access through the NHS.
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.
Structuring the clinical and economic evidence for payers.
Cost-effectiveness and budget-impact models.
Outcome and reimbursement data from routine practice.
Proof of clinical added value over the standard of care.
A cost-benefit argument for payers.
Impact on the health-system budget.
Alignment with national HTA methods.
An evidence-based basis for price and reimbursement.
Faster and broader access to patients.
Data quality means completeness, consistency and accuracy across all investigational sites.
Assessing data-source quality, completeness and consistency.
A robust protocol aligned with ISO 14155:2026 and GCP.
Site activation, in-house CRAs, high-quality data collection.
Rigorous statistical analysis of safety and performance.
Comprehensive reports for Notified Body and authorities.
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. »
No. Reimbursement and market access additionally require evidence of clinical benefit and cost-effectiveness for HTA bodies and payers.
Yes. We design studies so that they yield endpoints for both the Notified Body and HTA bodies.
Among others G-BA/IQWiG (Germany), HAS/CNEDiMTS (France) and NICE (United Kingdom).
A structured presentation of the clinical and economic evidence that proves the value of the device to payers.
As early as possible, ideally when the clinical investigation is being planned.
Talk to our team about value dossiers, HTA requirements and an evidence strategy that accelerates market access.
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