Equivalence is the most scrutinised argument in a clinical evaluation. We build device, biological and clinical equivalence to the higher EU MDR bar, and align it across the EU and UK regulatory frameworks.
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
Leading device manufacturers choose Eclevar for clinical evidence and real world evidence. Read all client success stories.
Dr Mark Da Costa, COO and former TÜV SÜD reviewer, knows exactly where equivalence arguments fail. We build technical, biological and clinical equivalence with the data access and rigour MDCG 2020-5 now demands, and align it across EU and UK routes.
Under the EU MDR and MDCG 2020-5, equivalence must be demonstrated across technical, biological and clinical characteristics, with sufficient access to the technical documentation of the equivalent device. Many legacy claims no longer pass.
We assess whether equivalence is genuinely defensible, close the gaps with targeted data where it is not, and keep the EU and UK positions aligned so one evaluation serves both markets.
All three must hold, with adequate access to the equivalent device data.
Design, specifications, conditions of use and deployment.
Materials, contact and duration in the same tissue environment.
Same clinical condition, purpose, site and population.
Eclevar deploys in-house Clinical Research Associates in the United Kingdom, Germany, France and Sweden, ensuring smooth study initiation, ethics-committee submissions (for example CPP in France) and high-quality clinical data collection.
Technical, biological and clinical mapping against MDCG 2020-5.
Targeted data where equivalence alone is insufficient.
One position aligned to EU MDR and UK MDR routes.
An equivalence argument that survives review.
Sufficient access to the equivalent device documentation.
Where own clinical data are still required.
A robust basis for the Clinical Evaluation Report.
One evaluation serving both markets.
Documentation that holds up under review.
Data quality means completeness, consistency and accuracy across all investigational sites.
Assessing data-source quality, completeness and consistency.
A robust protocol aligned with ISO 14155:2026 and GCP.
Site activation, in-house CRAs, high-quality data collection.
Rigorous statistical analysis of safety and performance.
Comprehensive reports for Notified Body and authorities.
Multicentre study with retrospective and prospective record data from French university hospitals (CHU Valenciennes, Nantes, Brest), covering carotid and femoral locations up to 3 years post-op and meeting EU MDR requirements for CE certification.
RegenLab needed PMCF data to renew its CE marking without disrupting clinical workflows. Eclevar designed a targeted RWE-PMCF registry study on the MILO EDC platform capturing wound-healing trajectories and adverse-event tracking.
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 clinical program.
Eclevar manages RegenLab's PMCF program on chronic wound devices: 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.
« Eclevar, with its tailor-made approach and advanced Milo Studio platform, represents a major strategic asset. »
Technical, biological and clinical equivalence, demonstrated per MDCG 2020-5, with sufficient access to the equivalent device’s technical documentation.
The MDR and MDCG 2020-5 raised the bar and require data access that many manufacturers do not have for a competitor device.
Yes; we align the argument to both EU MDR and UK MDR routes so a single evaluation supports both markets.
We identify the gap and design targeted clinical data (PMCF or a focused investigation) to close it.
A defensible equivalence position is often the backbone of the Clinical Evaluation Report; a weak one is the most common cause of rejection.
Talk to our team about your equivalence claim, the data access you need and the fastest compliant route across the EU and UK.
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