For MedTech teams planning PMCF or pivotal studies who need realistic recruitment forecasts and a country strategy that fits EU MDR, UKCA and Notified Body expectations, before a single site is activated.
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
Device leaders rely on Eclevar for feasibility and site selection across Europe. Read all client success stories.
Notified Bodies expect robust justification for your site selection and patient population representativeness. Dr Mark DaCosta, COO and former TÜV SÜD reviewer, ensures every feasibility report gives you a documented, data-backed rationale for each country and site, so recruitment holds and your choices survive review.
A comprehensive view covering recruitment reality, competing trials and regulatory context before you commit budget to your clinical programme. You receive:
A short slide pack capturing device, indication, target markets, endpoints, recruitment goals and key questions.
A country-by-country view of standard of care, patient pathways, reimbursement context and competing device studies.
A mapping of potential investigators and centres, patient volumes, prior device trial experience and KOL feedback.
A prioritised list split into Wave 1 and Wave 2, with a clear, data-backed rationale for every recommendation.
A model with projected monthly enrolment, expected start-up timelines and key risk flags, delivered in a strategic read-out.
A growing MedTech company was unsure which European countries and centres could realistically recruit within a limited budget.
Outcome: launched a lean study that met recruitment targets without amendments, with a data-based country choice demonstrated to Notified Bodies.An established manufacturer needed PMCF data for MDR on a Class III implant with routine follow-up concerns.
Outcome: steady enrolment generating RWD for the CER and PMCFER, with a clear site rationale for Notified Body review.A US-based company entered the EU market with limited knowledge of European healthcare systems.
Outcome: a three-country design with predictable timelines that met Ethics and Competent Authority expectations.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, useful for any feasibility and site selection plan.
Eclevar manages RegenLab's PMCF programme on chronic wound devices. This is 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, from protocol design through to final study report.
« Eclevar, with its tailor-made approach and advanced Milo Studio platform, represents a major strategic asset. »
It is the process of evaluating whether a clinical investigation or PMCF study can be successfully executed before committing budget, by assessing patient populations, site capabilities, competing studies and regulatory alignment.
Complex, high-risk devices from Class IIa to Class III across cardiovascular, advanced wound care, orthopedics and spine implants, neuromodulation and dental.
A standard feasibility project takes 4 to 5 weeks from the kick-off meeting to the final read-out session and delivery of the enrolment forecast model.
MILO EDC is recommended for EU MDR-native integration, but the team is platform agnostic and can work with your existing validated EDC systems if required.
Yes, through established strategic corridors and direct partnerships in LATAM (Brazil, Colombia), Japan (PMDA) and India.
Notified Bodies expect robust justification for your site selection and patient population representativeness. Feasibility reports provide the documented rationale to defend those choices during Notified Body reviews.
Book a consultation and we will scope your device, target countries and endpoints, then return a data-backed feasibility footprint and enrolment forecast.
Book a consultation