EU MDR 2017/745 demands a different kind of CRO: one where the clinical evidence strategy is designed the way regulators expect to see it, from protocol version 1. Eclevar delivers clinical operations, medical writing and data management 100% in-house, with former Notified Body reviewers on the team.
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 across cardiovascular, orthopaedics, wound care and more choose Eclevar. Read all client success stories.
Eclevar's model brings the regulatory perspective inside the CRO, eliminating the gap between what manufacturers submit and what assessors expect. Dr Mark DaCosta, COO and former TÜV SÜD reviewer, and Dr Nikhil Khadabadi, CMO for orthopaedics and spine and also a former TÜV SÜD senior reviewer, lead a team that designs clinical evidence exactly the way Notified Bodies expect to read it, from the first protocol version.
Under EU MDR, a device programme run on a pharma template is a programme built to fail inspection. The difference is structural.
Every franchise is led with dedicated senior attention and, where relevant, former Notified Body insight.
From complex TAVI pivotal programmes to IIS conversion, clinical evidence aligned with Notified Body expectations for Class III structural heart devices.
Explore ↗EWMA collaboration, chronic wound endpoints and PMCF strategies for NPWT systems and bioengineered tissue substitutes, with deep KOL networks across the EU.
Explore ↗Led by former TÜV SÜD assessors: Class IIb / III implants, registry-based PMCF and Annex XIV compliance for joint reconstruction and fusion.
Explore ↗Class III active implantable devices face rigorous requirements. We build 10-year PMCF architectures with AIMD-specific methodology.
Explore ↗Pre and post-market trials under ISO 14155. Site selection, monitoring and multi-country ethics submissions.
CER under MDCG 2020-6, PMCF Plans and SSCP, written by clinicians and reviewed by former Notified Body assessors.
100% in-house. eCRF design, DMP and DVP, powered by MILO Health, natively built for EU MDR.
Structured programmes meeting MDCG 2020-7 Level 4 criteria, with validated questionnaires and MILO capture.
National registry integration (NJR, EUDAMED) for long-term PMCF follow-up of implantable devices.
Clinical strategy for CE mark pathways and equivalence assessments delivered by former Notified Body experts.
Former Notified Body reviewers from TÜV SÜD. We know what fails inspection and design programmes to avoid it.
Clinical ops, writing and data management. One point of accountability, no handoff fragmentation.
Proprietary platform built natively for EU MDR, with Annex XIV mapping and AI eCRF generation.
Paris, London, Tokyo and Pune. In-house CRAs in 10 countries, not a network of subcontractors.
Platinum Award winner, EUCROF 2026, ranked first for clinical innovation and data strategy.
ISO 13485 certified. Every programme structured for TMF completeness and Notified Body inspection readiness.
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 high risk device programme.
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. »
Device programmes require strict adherence to ISO 14155:2026, endpoints mapped to General Safety and Performance Requirements, proactive registry-based PMCF under Annex XIV Part B and Notified Body insight. Generalist pharma CROs default to ICH-GCP and treat PMCF as passive surveillance. Eclevar is built natively for devices, with strategies designed by former Notified Body reviewers.
Clinical operations and PMCF investigations under ISO 14155, medical writing (CER under MDCG 2020-6, PMCF Plans, SSCP), 100% in-house clinical data management on the MILO Health EDC, Level 4 PMCF surveys under MDCG 2020-7, registry-based real world evidence and EU MDR regulatory strategy.
Cardiovascular and structural heart, orthopaedics and spine, dental devices, neuromodulation and neuro-implants, and advanced wound care, regenerative and aesthetic devices, each with a dedicated specialist practice.
Clinical operations, medical writing and data management are 100% in-house, with one point of accountability and no handoff fragmentation, and in-house CRAs across the top EU countries rather than a network of subcontractors.
Yes. Eclevar is ISO 13485 certified and structures every programme for trial master file completeness and Notified Body inspection readiness from day one, informed by former Notified Body reviewers who know what fails inspection.
MILO Health is Eclevar's proprietary electronic data capture platform, built natively for EU MDR with Annex XIV mapping and validation to 21 CFR Part 11 and ISO 14155:2026, and the award-winning trial forecasting engine recognised at the xShare and EUCROF 2026 Open Call.
Talk to our specialists about your device, your target markets and the fastest compliant route to Notified Body ready clinical evidence.
Book a consultation