Eclevar MedTech delivers specialist EU MDR clinical programmes across the full tissue repair spectrum: advanced wound management, bioengineered tissue, PRP and regenerative systems, and aesthetic medical devices, each with clinical evidence built to satisfy Notified Body review without findings.
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
From advanced wound care to regenerative and aesthetic devices, manufacturers choose Eclevar as their specialist CRO. Read all client success stories.
Eclevar's regulatory leadership was built inside Notified Bodies. Dr Mark DaCosta, COO and former TÜV SÜD reviewer, sets the standard the whole team works to: clinical evidence designed exactly the way reviewers expect to read it. For tissue repair, that means wound, regenerative and aesthetic endpoints that translate biological effects into evidence a Notified Body can accept, from the first protocol version.
Advanced wound care, regenerative medicine and aesthetics share one regulatory challenge: generating clinical evidence for tissue effects that are inherently complex, heterogeneous and difficult to standardise. Our clinical programmes are built for exactly that challenge.
PMCF programmes for the full advanced wound care portfolio: NPWT, bioengineered tissue substitutes, antimicrobial dressings and compression systems for diabetic foot ulcer (DFU), venous leg ulcer (VLU) and pressure injuries. EWMA collaboration for investigator access and REDIT registry integration.
Clinical investigations and PMCF for autologous platelet concentration systems (PRP/PRF), cellular and acellular dermal matrices and growth factor carriers, with full ATMP borderline analysis for accurate classification under EU MDR. Endpoints capture biological mechanisms and tissue regeneration outcomes.
Rigorous clinical evidence for Class IIb and Class III aesthetic devices: HA fillers, collagen biostimulators, aesthetic threads, breast implants and energy-based devices (laser, RF, HIFU). Validated aesthetic PROs, 36-month durability tracking and delayed adverse event surveillance under Annex XVI.
Chronic wounds are among the most clinically complex indication areas in EU MDR. Wound size, etiology, comorbidities and treatment variability create a heterogeneous evidence challenge that generic CRO survey programmes cannot solve. Our specialist team has designed dedicated PMCF frameworks for the specific evidence challenge of each wound category.
PMCF for portable and stationary NPWT devices. Endpoints include wound area reduction rate, granulation tissue quality and time to wound bed preparation, with photographic wound assessment standardised via a measurement charter and REDIT registry linkage for French population data.
CER and PMCF for acellular and cellular skin substitutes, dermal matrices and regenerative dressings. Equivalence analysis under EU MDR Article 61(4) for established product families, and first-in-class clinical investigation design where equivalence is not available.
PMCF Level 4 survey programmes for large antimicrobial dressing portfolios across multiple wound categories and populations. HCP-facing structured outcome surveys with antimicrobial performance sub-scales, biofilm assessment integration and safety signal tracking.
PMCF for multilayer compression bandaging, compression hosiery and intermittent pneumatic compression devices, with Aberdeen Varicose Vein Questionnaire (AVVQ) and VLU-QoL integration and an ABI measurement standardisation protocol across sites.
Regenerative medicine devices sit at the most complex intersection in EU MDR: between medical devices, biologics and Advanced Therapy Medicinal Products (ATMPs). A platelet-rich plasma (PRP) system that concentrates autologous platelets and delivers growth factors to a wound bed is regulated as a medical device in most EU jurisdictions, yet its evidence requirements demand the biological mechanism data, dose-response characterisation and long-term safety follow-up expected of a pharmaceutical.
Eclevar has developed a dedicated regenerative medicine evidence framework that addresses this complexity directly. Our partnership with RegenLab, a leading PRP and cell therapy device company in Europe, has shaped a rigorous PMCF methodology for autologous PRP systems used in advanced wound care, musculoskeletal regeneration and aesthetic restoration.
Aesthetic medical devices without a primary medical purpose face the strictest clinical evidence scrutiny under EU MDR Annex XVI. Eclevar designs PMCF programmes specifically for aesthetic endpoints, durability tracking and delayed adverse event surveillance.
Wound surface area via digital planimetry or photographic capture, wound depth, undermining and exudate per the PUSH Tool v3.0 or TIME framework, and time-to-event analysis for wound closure using Kaplan-Meier modelling.
Tissue regeneration quality via histological scoring and the Bates-Jensen Wound Assessment Tool (BWAT). For PRP studies, platelet concentration factor quantification and growth factor analysis including VEGF, PDGF and TGF-beta.
Cardiff Wound Impact Schedule (CWIS) for multi-domain wound assessment and Wound-QoL for chronic wound metrics, with general utility via EQ-5D-5L and wound-related pain VAS, MCID pre-specified from peer-reviewed literature.
Global Aesthetic Improvement Scale (GAIS), FACE-Q scales for facial aesthetic outcomes and the Fitzpatrick Wrinkle Scale, plus standardised filler assessment and the Body Image Scale licensed from MAPI Research Trust.
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, advanced wound care and regenerative devices included.
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. »
A Notified Body perspective on the designation, evidence generation and conformity assessment of breakthrough devices under the EU MDR. Joint publication to come.
Dr Nikhil KhadabadiCMO · Eclevar MedTechLook for wound specific endpoint expertise (wound area reduction, PUSH Tool, TIME, wound specific quality of life), access to a wound investigator network such as EWMA, credible PMCF and registry design, and Notified Body insight on the team. Eclevar combines all four, with an EWMA collaboration model and a former Notified Body reviewer in the leadership team.
PMCF for NPWT, bioengineered tissue, antimicrobial dressings and compression uses wound area reduction, time to closure by Kaplan-Meier, wound bed quality (PUSH Tool v3.0, TIME) and validated wound quality of life instruments, deployed through multi-site surveys and registry linkage such as REDIT.
An autologous platelet-rich plasma preparation system that concentrates platelets and delivers growth factors is regulated as a medical device in most EU jurisdictions, but the borderline with Advanced Therapy Medicinal Products must be assessed case by case. Eclevar provides full ATMP borderline analysis to confirm the classification before evidence generation.
Aesthetic devices without a medical purpose face strict clinical evidence scrutiny under EU MDR Annex XVI. Eclevar designs PMCF programmes with validated aesthetic PROs (GAIS, FACE-Q, BODY-Q), 12 to 36 month durability tracking and delayed adverse event surveillance.
Through collaboration with the European Wound Management Association, Eclevar accesses a network of over five hundred wound care specialist investigators across thirty-seven European countries, enabling rapid multi-site survey and registry deployment without the site activation delays of general study networks.
Yes. Eclevar manages RegenLab's PMCF programme on chronic wound devices: a randomized study of 160 patients across 14 sites in 5 EU countries covering diabetic foot ulcer and venous leg ulcer indications, combining ISO 14155 clinical expertise with the Milo Studio platform.
Book a free thirty-minute clinical strategy call with an Eclevar specialist. We assess your current evidence gaps, identify the most efficient PMCF pathway for your device and provide a clear timeline to Notified Body compliant evidence.
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