Not all surveys are equal. Eclevar Medtech designs Level 4 high-quality surveys that Notified Bodies accept as primary clinical evidence.
MDCG 2020-7 Compliant methodology for primary evidence.
Built to withstand the most rigorous clinical reviews.
Pre-specified MCID and psychometric verification.
A PMCF survey is a structured data collection instrument deployed to address specific knowledge gaps identified in your CER.
The word "survey" is often misleading. High-quality Level 4 surveys are functionally equivalent to clinical investigations in their methodological requirements.
A survey without a pre-specified Statistical Analysis Plan (SAP) is not MDCG 2020-7 compliant. Post-hoc analysis is a standard Notified Body finding.
We begin with the evidence gaps in your PMCF Plan. Every instrument uses pre-specified endpoints, validated scales, and MCID thresholds defined before data collection begins.
Scientific questionnaires with published psychometric properties. No custom marketing forms.
Sample size justification and MCID success criteria defined before first response.
Minimum of 3-5 sites with training and monitoring consistent with ISO 14155.
Every objective must map to a specific residual risk in the PMCF Evaluation Report.
Approval required for patient-facing surveys. Eclevar prepares the full dossier.
The only level acceptable for CER updates of Class IIb and Class III devices.
Captures clinical performance and operator-reported outcomes from HCPs.
Licensed PROM instruments deployed to collect functional outcome data.
When multiple variants (guidewires, spinal screws) need evidence simultaneously. A structured survey is the only feasible strategy under MDR Article 61(2).
Class III implantables requiring 5-10 years of surveillance beyond initial trials. Annual clinician surveys provide the continuous data stream needed.
Generate targeted quality-of-life evidence in 4-8 months to meet recertification timelines when a full trial (2-3 years) is too slow.
Capture experience in populations typically excluded from trials (comorbid, elderly). Address Notified Body feedback with broader data.
CER residual risks mapped to Annex XIV objectives.
Validated tools selected and SAP finalized.
Full submission and approval management.
Qualified sites activated on MILO platform.
Database lock and PMCFER authoring.
The MILO platform includes a native eCOA/ePRO module. Every response is timestamped, immutably stored, and exportable with a SHA-256 checksum for 21 CFR Part 11 compliance.
Objectives, criteria, and site specs for NB review.
Power calculation and MCID thresholds.
Full submission package including ICF and GDPR.
Validated configuration with real-time dashboard.
Full ICH E3 structured reporting.
Traceable evidence closing CER gaps.
| Category | Class | Primary Evidence | Service |
|---|---|---|---|
| NPWT Devices | IIb | Level 4 HCP survey, 12-week follow-up. | PMCF Survey |
| Bioengineered Tissue | III | Investigation or high-quality Level 4 survey. | Level 4 Survey |
| HA Dermal Fillers | III | PMCF study with GAIS, FACE-Q, 24mo tracking. | PMCF Study |
Book a free PMCF Survey Gap Assessment. We will outline exactly what is required to achieve approval in a single round.
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