For high-risk devices and innovations, we design and run premarket clinical investigations to ISO 14155:2026 that deliver the clinical evidence for CE marking.
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 DaCosta, COO and former TÜV SÜD reviewer, knows what clinical evidence a Notified Body expects before CE marking. We design premarket investigations so that study design, endpoints and data quality hold up under review.
For novel and high-risk devices, literature alone is not enough. The EU MDR often requires a dedicated clinical investigation to demonstrate safety and performance before market entry.
A solid premarket investigation defines the clinical question, selects meaningful endpoints and delivers the data that underpins the Clinical Evaluation Report.
We choose the design that delivers the evidence with the least burden on your sites.
Early safety and feasibility data for innovations.
Confirmatory study to demonstrate safety and performance.
Comparison with standard of care where required.
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.
Scientifically sound design with meaningful endpoints.
Selection and activation of suitable sites in the CHU network.
eCRF and monitoring on the MILO EDC platform.
Demonstrating an acceptable benefit-risk profile.
Proving clinical performance at the intended purpose.
Meaningful, measurable clinical endpoints.
Data that underpins the Clinical Evaluation Report.
Documentation that holds up under Notified Body review.
A seamless handover into post-market follow-up.
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.
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.
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.
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. »
Mostly for Class III and implantable devices, and for innovations where insufficient equivalence data exist.
ISO 14155:2026 and GCP, aligned with EU MDR 2017/745.
From the intended purpose, the state of the art and the Notified Body’s expectations of measurable clinical outcomes.
Yes, our in-house CRAs coordinate submissions to the relevant ethics committees.
The premarket investigation feeds into a PMCF plan for continuous follow-up.
Talk to our team about study design, sites and the fastest compliant route to Notified Body ready clinical evidence.
Book a free callOur team works closely with you to develop a trial design that answers your scientific questions while meeting all regulatory requirements. We consider:
Years of experience managing successful pre-market clinical trials
Physicians, clinical researchers, and regulatory specialists
Advanced EDC platform for efficient data management
Strong partnerships with clinical sites across Europe
Our proprietary EDC platform streamlines data collection and management throughout your clinical trial.
A pre-market clinical investigation is a study conducted on a medical device that is not yet CE marked. It is designed to generate clinical data to support the safety and performance claims required for regulatory approval under the MDR.
The duration varies depending on the device, study design, and patient recruitment. On average, pre-market clinical trials take 12-18 months from protocol approval to final report submission.
Pre-market trials must comply with MDR requirements including proper protocol design, ethics committee approval, informed consent procedures, adverse event reporting, and comprehensive documentation of all trial activities.
We leverage our extensive network of clinical sites and use AI-powered tools within the Milo Healthcare platform to identify and recruit eligible patients efficiently, reducing recruitment timelines and costs.
You will receive a comprehensive Clinical Investigation Report (CIR) that includes all study data, statistical analysis, safety assessments, and conclusions. This report is designed to support your regulatory submission for CE marking.
Our team of experts is ready to guide you through every step of your clinical investigation. Schedule a consultation to discuss your project.
