Dermal fillers are Class III. Annex XVI brought aesthetic devices into EU MDR scope. Eclevar MedTech turns both into clinical evidence that passes Notified Body review: clinical investigations under ISO 14155, CER, and PMCF with validated aesthetic scales, executed across France, the UK and Germany.
The top Platinum Award went to Milo Health, the technology platform developed by Eclevar MedTech, at the xShare Open Call for Clinical Research organised by EUCROF. The same platform powers our aesthetic ePRO and PMCF data collection.
Platinum Award, xShare Open Call for Clinical Research, organised by EUCROF and co-funded by the European Union. Amsterdam, 2 February 2026. Horizon Europe, Grant Agreement No. 101136734.
Whether your product is a Class III injectable, an energy-based platform, or an Annex XVI device without a medical purpose, the evidence path runs through the same reviewers. We build for them.
CE marking trials for Class III injectable fillers: protocol, Annex XV submission, ISO 14155 execution, blinded evaluation on validated wrinkle and volume scales.
How we build the evidence →Lasers, IPL, lipolysis, body contouring and fillers without a medical purpose: clinical evaluation and PMS aligned with the Common Specifications of Regulation (EU) 2022/2346.
How we build the evidence →Clinical Evaluation Reports and Level 4 PMCF programmes using validated patient-reported instruments such as FACE-Q and aesthetic improvement scales, deployed as ePRO.
See our PMCF page →Annex XVI of the EU MDR brought products without an intended medical purpose into full regulatory scope: dermal fillers for aesthetic use, equipment for liposuction and lipolysis, and high-intensity electromagnetic radiation equipment such as lasers and IPL. The Common Specifications of Regulation (EU) 2022/2346 set the bar.
For injectable fillers, EU MDR classification places most products in Class III, the same risk class as a heart valve. The clinical evidence is judged accordingly: subjective beauty claims do not survive review, pre-specified endpoints on validated scales do.
Supporting aesthetic efficacy claims with before-and-after photos and satisfaction questionnaires. Without validated scales, blinded evaluation and a pre-specified analysis plan, that data cannot stand as clinical evidence and is a frequent trigger of Notified Body deficiencies.
Wrinkle severity, volume and improvement scales with published validation, plus FACE-Q patient-reported modules.
Independent blinded evaluators and standardised photography so efficacy holds up under scrutiny.
Multi-site, multi-country execution with trained sites, monitoring and competent authority submissions.
Systematic follow-up of injection-site and delayed events, with durability data strengthening every renewal.
From first CE marking of an injectable to keeping a marketed aesthetics portfolio compliant.
For new Class III fillers and Annex XVI devices that need premarket clinical data.
Clinical Evaluation Reports built for fillers, energy-based devices and Annex XVI products.
Level 4 PMCF surveys and registries tailored to aesthetic outcomes and durability.
A Class III injectable heading to its first European submission, needing investigation-grade efficacy and safety data.
An aesthetic device without a medical purpose now in MDR scope, needing clinical evaluation under the Common Specifications.
Findings on aesthetic claims or PMCF quality, answered by a team that includes a former Notified Body reviewer.
New indications, volumes or anatomical areas across a filler family, with evidence planned under MDR Article 61(2).
Coloplast, a global leader in intimate healthcare, is among the manufacturers that rely on Eclevar for clinical evidence in Europe.
Eclevar transformed complex Notified Body inquiries into a structured response strategy, leading to a successful Class III review with zero Major Non-Conformance Reports: the rigour your Class III filler file needs.
"The evaluation pinpointed areas needing improvement with color-coded clarity. Eclevar's insights have been instrumental in addressing inquiries from the Notified Body."Seiichi Tanaka, Asahi Intecc
Eclevar manages all upcoming PMCF studies on chronic diabetic foot ulcer devices for RegenLab, the PRP and cell therapy specialists, applying the same PROM-driven methodology we bring to aesthetic injectables.
"Eclevar, with its tailor-made approach and advanced MILO Studio platform, represents a major strategic asset."Antoine Turzi, CEO, RegenLab
The award-winning MILO engine reads your protocol and returns three costed scenarios plus a recruitment forecast anchored to real European site data, so an aesthetics programme starts with a budget, not a guess.
The same platform runs your ePRO collection: every FACE-Q response timestamped, stored immutably, and exportable with a SHA-256 checksum for 21 CFR Part 11 compliance.
Your aesthetics programme is designed and challenged by people who have sat on the reviewer's side of the table.
Cardiac surgeon and former senior reviewer at a Notified Body (TÜV SÜD). He challenges every design the way your reviewer will.
Leads clinical strategy across implantable device programmes, from protocol to publication.
Turns aesthetic study outputs into CER-ready evidence with full traceability to your PMCF Plan.
Owns the MILO ePRO stack, data integrity and 21 CFR Part 11 compliant exports.
Pilote la réalisation des investigations cliniques et études PMCF en Europe. Qualification des sites, monitoring, TMF, ISO 14155:2026. Master Ingénierie de la Santé (Université Grenoble Alpes). Parcours : recherche clinique, cardiovasculaire, usability medical devices.
Your first point of contact for scoping calls, proposals and partnership programmes.
Where our consultants, including our former Notified Body expert, are presenting and what we are building. Come and find us, or book a call.
The Eclevar team, including our former Notified Body expert, on what device trials need to satisfy Notified Body review.
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Prof. Mark DaCosta, COO and former Notified Body expert, joins the CSI Frankfurt speaker panel on EU MDR and the introduction of new devices.
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Our award-winning platform reads a protocol and returns three costed scenarios, swift, base and conservative, plus a recruitment forecast.
Explore the platform ↗Practical references written by our consultants. Enter your business email to unlock the download.
What the Common Specifications of Regulation (EU) 2022/2346 actually require, and the evidence path that satisfies them.
How a former Notified Body reviewer structures responses that close findings instead of reopening them.
Where EU MDR clinical evaluation is heading and what it means for your PMCF and CER cycles.
Book a scoping call for your filler or aesthetic device programme. We will define exactly what your file needs, from Annex XVI gap analysis to a full clinical investigation.
Book a free scoping call