Not all surveys are created equal. Eclevar MedTech designs Level 4 PMCF surveys for medical devices: MDCG 2020-7 compliant instruments accepted by Notified Bodies as primary clinical evidence, executed across France, the UK, Germany and beyond.
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 now powers our 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.
Three families of PMCF surveys, each mapped to a specific evidence gap in your Clinical Evaluation Report.
Clinical outcome surveys completed by healthcare professionals. The highest regulatory weight according to MDCG 2020-7, designed prospectively with pre-specified endpoints.
See Level 4 requirements →Validated PROM and ePRO instruments, licensed and scored according to developer specifications, with MCID thresholds pre-specified before the first response is collected.
See Level 4 requirements →Surveys coupled with national implant registry data such as NJR or EPRD, giving long-term cross-validation of your clinical claims against real-world cohorts.
See Level 4 requirements →A PMCF survey is a structured data collection instrument designed to fill the gaps identified in your Clinical Evaluation Report. The word "survey" is often misleading: Level 4 surveys are methodologically equivalent to clinical investigations.
That is why Eclevar starts from the gaps in your PMCF Plan. Every instrument uses pre-specified endpoints, validated scales and defined MCID thresholds before collection begins, so the data lands as primary clinical evidence, not as supporting context.
A survey without a pre-specified Statistical Analysis Plan (SAP) is not MDCG 2020-7 compliant. Post-hoc analysis is one of the most frequent causes of non-compliance raised by Notified Body reviewers.
Scientific questionnaires with published psychometric properties. No marketing-style forms.
Sample size justification and MCID success criteria fixed before the first data point.
Site training and monitoring compliant with ISO 14155:2020, across countries where needed.
Each survey objective corresponds to a specific residual risk from the evaluation report.
From primary evidence for Class IIb and III recertification to focused clinician and patient instruments.
The only tier acceptable for CER updates of Class IIb and III devices.
Captures clinical performance and operator-reported outcomes from healthcare professionals.
Licensed PROM instruments to collect functional outcome data directly from patients.
When multiple variants require evidence simultaneously. An efficient strategy under MDR Article 61(2).
Class III implants requiring 5 to 10 years of surveillance following the initial trials.
Generate quality-of-life evidence within 4 to 8 months to meet recertification deadlines.
Capture experience in populations excluded from trials, such as elderly patients or those with comorbidities.
When Nihon Kohden needed to align the EEG-1200K with European Notified Body expectations, Eclevar rebuilt the clinical strategy and structured the PMCF programme so the evidence answered exactly what reviewers expect from a neuro device under MDR.
"Eclevar shared their expertise in a way that allowed us to create documentation perfectly adapted to our needs. The team responded promptly and flexibly." Product Manager, Nihon Kohden Corporation
Design and execution of PMCF surveys providing primary clinical evidence for Class III cardiovascular and orthopaedic portfolios across multiple European sites.
Structured PMCF strategies and equivalence assessments integrated directly into CERs, generating compliant post-market evidence for advanced dental and restorative technologies.
Eclevar MedTech is backed by institutional investors. We are privately owned and backed by private investors and venture capital, giving sponsors the stability of a partner built to follow Class III devices through 5 to 10 years of post-market surveillance.
Funding & investorsYour PMCF survey 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 for orthopaedic and spine devices, including registry-linked PMCF programmes.
Turns survey outputs into CER-ready evidence with full traceability to your PMCF Plan.
Owns the MILO eCOA and 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 14155:2020. Master Ingénierie de la Santé (Université Grenoble Alpes). Parcours : recherche clinique, cardiovasculaire, usability medical devices.
Your first contact for scoping calls, PMCF strategy alignment and sponsor relationships.
The Eclevar team, including our former Notified Body expert, on what cardiovascular trials and PMCF programmes need to satisfy Notified Body review.
Book a meeting ↗
Prof. Mark DaCosta, COO and former Notified Body expert, joins the CSI Frankfurt speaker panel on EU MDR and the introduction of new devices.
See the session ↗
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.
How to architect PMCF surveys and registries that satisfy Notified Bodies without draining your clinical budget.
Choosing between licensed PROMs, clinician surveys and national registry linkage for long-term safety data.
Where EU MDR clinical evaluation is heading and what it means for your PMCF and CER cycles.
Book a gap analysis for your PMCF surveys. We will define exactly what is required to get approval on the first try.
Book a strategic call