Eclevar Medtech delivers specialized EU MDR clinical programs for the full tissue repair and regenerative medicine spectrum. Advanced wound management, bioengineered tissue, PRP systems, and aesthetic medical devices — each with clinical evidence built to satisfy Notified Body review without findings.
NPWT, bioengineered tissue, antimicrobial dressings, compression, and chronic wound devices. Access to EWMA registries and specialized endpoints.
Autologous platelet concentration systems, acellular dermal matrices, and musculoskeletal regenerative programs. Expert ATMP borderline analysis.
HA fillers, biostimulators, breast implants, and energy-based aesthetic devices. Utilization of FACE-Q, BODY-Q, and 36-month durability protocols.
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 standardize. The clinical programs at Eclevar Medtech are built for exactly that challenge.
Eclevar Medtech provides PMCF programs for the full Advanced Wound Care portfolio. This includes negative pressure wound therapy (NPWT), bioengineered tissue substitutes, antimicrobial dressings, and compression systems for diabetic foot ulcer (DFU), venous leg ulcer (VLU), and pressure injuries.
We utilize an EWMA collaboration model for investigator access and REDIT registry integration. Our endpoint frameworks include wound area reduction, TIME assessment, PUSH tool, and validated wound-specific Quality of Life instruments.
We deliver clinical investigations and PMCF programs for autologous platelet concentration systems (PRP/PRF), cellular and acellular dermal matrices, and growth factor delivery carriers. We provide full ATMP borderline analysis to ensure accurate regulatory classification under EU MDR.
Through our exclusive clinical partnership with RegenLab, we design endpoint architectures that capture biological mechanisms of action and clinical tissue regeneration outcomes across Advanced Wound Care and musculoskeletal indications.
Eclevar Medtech provides rigorous clinical evidence generation for Class IIb and Class III aesthetic medical devices. We manage PMCF programs for hyaluronic acid fillers, collagen biostimulators, aesthetic threads, breast implants, and energy-based devices (Laser/RF/HIFU).
We implement MAPI Research Trust PROs (FACE-Q, BODY-Q), 36-month durability tracking protocols, and delayed adverse event surveillance architectures required by the Notified Body for high-risk aesthetic injectables.
Chronic wounds are among the most clinically complex indication areas in EU MDR. Wound size, etiology, patient comorbidities, and treatment variability create a heterogeneous evidence challenge that generic CRO survey programs cannot solve. The Eclevar Medtech specialized team has designed dedicated PMCF frameworks for the specific evidence challenges of each wound category.
Collaboration with EWMA (European Wound Management Association) provides Eclevar Medtech with access to a network of over five hundred wound care specialists across thirty-seven European countries. This enables rapid multi-site survey and registry study deployment without the site activation delays that characterize general clinical study site networks.
PMCF programs for portable and stationary NPWT devices. Primary endpoints include wound area reduction rate, granulation tissue quality, and time to wound bed preparation. Multi-centre survey with photographic wound assessment protocol standardised via Measurement Charter. Registry linkage with REDIT for French population data.
CER and PMCF programs for acellular and cellular skin substitutes, dermal matrices, and regenerative wound dressings. Equivalence analysis under EU MDR Article 61(4) for established product families. First-in-class clinical investigation design where equivalence is not available.
PMCF Level 4 survey programs for large antimicrobial dressing portfolios covering multiple wound categories and patient populations. HCP-facing structured outcome surveys with antimicrobial performance sub-scales, biofilm assessment integration, and safety signals tracking.
PMCF programs for multilayer compression bandaging, compression hosiery, and intermittent pneumatic compression devices. Aberdeen Varicose Vein Questionnaire (AVVQ) and VLU-QoL instrument integration. ABI measurement standardisation protocol across sites.
Wound area reduction (%), time to 50% closure, and time to complete closure (Kaplan-Meier).
PUSH Tool v3.0, TIME assessment framework, and granulation and slough quantification.
Cardiff Wound Impact Schedule (CWIS), EQ-5D-5L, Wound-QoL, and pain VAS.
AE rate, wound infection incidence, MRSA/colonisation tracking, and serious AE reporting.
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) preparation system that concentrates autologous platelets and delivers growth factors to a wound bed is regulated as a medical device in most EU jurisdictions. However, its clinical evidence requirements demand the same depth of biological mechanism data, dose-response characterisation, and long-term safety follow-up that would be expected of a pharmaceutical.
Eclevar Medtech has developed a dedicated regenerative medicine clinical evidence framework that addresses this complexity directly. Our partnership with RegenLab, one of the leading PRP and cell therapy device companies in Europe, has shaped a rigorous PMCF methodology for autologous platelet-rich plasma 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 Medtech designs PMCF programs specifically for aesthetic endpoints, durability tracking, and delayed adverse event surveillance.
Eclevar Medtech utilizes wound surface area measurement through digital planimetry or photographic capture. We assess wound depth, undermining, and exudate levels per the PUSH Tool v3.0 or the TIME framework. We perform time-to-event analysis for wound closure using Kaplan-Meier modeling.
Tissue regeneration quality is assessed via histological scoring and the Bates-Jensen Wound Assessment Tool (BWAT). For Platelet-Rich Plasma studies, we provide platelet concentration factor quantification and growth factor analysis including VEGF, PDGF, and TGF-beta.
We implement the Cardiff Wound Impact Schedule (CWIS) for multi-domain wound assessment and Wound-QoL for chronic wound metrics. This includes general utility via EQ-5D-5L and wound-related pain VAS, with MCID pre-specified from peer-reviewed literature.
Our protocols include the Global Aesthetic Improvement Scale (GAIS), FACE-Q scales for facial aesthetic outcomes, and the Fitzpatrick Wrinkle Scale. We utilize standardized aesthetic scales for filler assessment and the Body Image Scale licensed from MAPI Research Trust.
Book a free thirty-minute clinical strategy call with an Eclevar Medtech specialist. We will assess your current evidence gaps, identify the most efficient PMCF pathway for your device, and provide a clear timeline to Notified Body compliant evidence.
