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 MedTech is built by former Notified Body reviewers, for device manufacturers who cannot afford to fail inspection.
EUCROF (European CRO Federation), Amsterdam, 2 February 2026. Ranked first among all European CROs for clinical innovation, real-world evidence strategy, and EHDS-aligned data architecture.
Under the MDD, many manufacturers relied on generalist pharmaceutical CROs. Under the strict clinical scrutiny of EU MDR Article 61, treating a medical device like a drug often leads to protocol rejections and non-conformities.
| Clinical Standard & Approach | Generalist Pharma CRO | Specialized MedTech CRO (Eclevar) |
|---|---|---|
| Core Regulatory Framework | Defaults to ICH-GCP (E6), forcing inappropriate pharmaceutical models onto device trials. | Strict adherence to ISO 14155:2020, the mandatory Good Clinical Practice standard for medical devices. |
| High-Risk Device Expertise | Rarely handles Class IIb/III implants. Lacks deep understanding of MDCG 2020-6 requirements. | Specialized in Class IIb and Class III implantable devices. Clinical strategies built by former Notified Body reviewers. |
| Clinical Endpoint Design | Struggles with operator-dependent variables and medical device learning curves. | Endpoints explicitly mapped to General Safety and Performance Requirements (GSPRs) of Annex I. |
| Post-Market Approach | Treats PMCF as passive Phase IV surveillance. | Designs proactive, registry-based or observational PMCF studies required by Annex XIV Part B. |
| Data Management (EDC) | Uses heavy, expensive legacy systems built for decades-long drug trials. | Utilizes MILO Health, the only EDC system built natively for agile medical device and PMCF trials. |
Most CROs build clinical programs and then adapt them to what regulators expect. Eclevar does the opposite. Because our founding team includes former Notified Body reviewers from TUV SUD, we know exactly what an assessor looks for when they open a technical file — and we design every program to pass that scrutiny from day one.
Under EU MDR 2017/745, a clinical evaluation report that was not built with Notified Body expectations in mind is not a starting point — it is a liability. Our team has reviewed hundreds of technical files from the other side of the table. That institutional knowledge is embedded in every protocol, every CER, and every PMCF plan we produce.
The result is clinical evidence that does not need to be restructured for submission. Programs that are not caught off guard by MDCG guidance updates. Data packages that withstand scrutiny because they were designed by people who once performed that scrutiny professionally.
Founded Eclevar MedTech to bring the regulatory perspective inside the CRO model — eliminating the gap between what manufacturers submit and what assessors expect.
Former Senior Reviewer at TUV SUD. Expert in Class IIb and III implantable device clinical evidence, registry-based PMCF, and Annex XIV compliance for orthopaedic and spine programs.
Generic CRO experience is not sufficient for EU MDR. Each therapeutic area has specific Notified Body expectations, endpoint standards, and PMCF requirements. Our teams are structured by vertical — not generalist.
From complex TAVI pivotal programs to investigator-initiated study conversion under EU MDR, our cardiovascular team designs clinical evidence strategies aligned with VARC-3 endpoints and current Notified Body expectations for Class III structural heart devices.
Explore our Cardiovascular expertiseEWMA collaboration, chronic wound endpoints, and PMCF strategies for NPWT systems, bioengineered tissue substitutes, and antimicrobial dressings. Our wound care team brings KOL depth and registry access across France, UK, and Germany.
Explore our Wound Care expertiseLed by Dr. Nikhil Khadabadi (former TUV SUD), our orthopedic and spine practice covers Class IIb and III implantable device programs, NJR and EPRD registry-based PMCF, radiographic measurement charters, and Annex XIV compliance for joint reconstruction and spine fusion devices.
Explore our Ortho & Spine expertiseClass III active implantable medical devices under EU MDR face among the most rigorous clinical evidence requirements. Our neuromodulation practice covers SCS, DBS, cochlear, and peripheral nerve stimulation programs — with 10-year PMCF architectures and AIMD-specific clinical evaluation methodology.
Explore our Neuromodulation expertiseNo outsourcing. No fragmented pipelines. Clinical operations, medical writing, and data management delivered by a single integrated team.
Pre-market and post-market clinical trials under ISO 14155:2020. Site selection, CRA monitoring, multi-country ethics submissions, and end-to-end study management.
PMCF studiesCER under MDCG 2020-6, PMCF Plans and Reports, SSCP, CIP, and protocol design. Written by clinicians, reviewed by former Notified Body assessors.
CER services100% in-house data management. eCRF design, DMP, DVP, query management, database lock. Powered by MILO Health — the only EDC built natively for EU MDR.
Data managementStructured PMCF survey programs meeting MDCG 2020-7 Level 4 quality criteria. Validated questionnaires, site network, and MILO Health data capture for registry-ready output.
Level 4 surveysNational registry integration (NJR, EPRD, Swespine, EUDAMED) for long-term PMCF follow-up. Real-world evidence strategies for Class IIb and III implantable devices.
RWE servicesClinical strategy for CE mark pathways, equivalence assessment (EU, UK, US), SSCP drafting, and EUDAMED registration support. Delivered by former Notified Body experts.
Regulatory consultingThere are hundreds of CROs. Very few were built specifically for EU MDR. Fewer still have former Notified Body reviewers on their executive team.
Our founding team includes former NB reviewers from TUV SUD. We know what fails inspection before submission — and we design programs to avoid those failure modes at the protocol stage.
Clinical operations, medical writing, and data management are delivered by our internal teams — not subcontracted. One point of accountability. No handoff fragmentation. No version control risk.
Our proprietary EDC platform is the only system built natively for EU MDR, with Annex XIV mapping, AI eCRF generation, and real-time inspection readiness scoring as core architecture — not add-ons.
Paris, London, Tokyo, Pune, Mauritius. In-house CRAs in France, Germany, UK, Italy, Spain, Sweden, Denmark, Brazil, Colombia, and Japan — not a network of subcontractors.
Platinum Award winner at the xShare Open Call for Clinical Research, organised by EUCROF and co-funded by the European Commission. Ranked first for clinical innovation and EHDS-aligned data strategy.
ISO 13485:2016 certified. Every program is structured for TMF completeness, CAPA traceability, and Notified Body inspection readiness — from the first protocol version, not at the point of submission.
Eclevar MedTech operates across the EU, UK, Japan, and India with in-house clinical research associates — not third-party monitoring networks. Our geographic coverage is built for EU-Japan PMDA corridors, MHRA post-Brexit pathways, and multi-country European investigations.
Our team of former Notified Body reviewers and EU MDR specialists will assess your program requirements and design a clinical investigation architecture that is built to pass inspection — from protocol version 1.
