PMCF Surveys · EU MDR Annex XIV
PMCF Surveys that
generate real
clinical evidence.
Not all surveys are created equal. Eclevar Medtech designs high-quality Level 4 surveys, accepted by Notified Bodies as primary clinical evidence.
Level 4
Quality Standard
MDCG 2020-7 compliant methodology for primary evidence.
Annex XIV
Acceptability
Built to withstand the most rigorous clinical examinations.
Validated
Instruments
Pre-specified MCID and psychometric verification.
MDCG 2020-7 Compliant
Validated Instruments
Primary Evidence Data
Multi-Site Execution
PMCF Survey Options
The right instrument for your data.
👨⚕️
Clinician-Focused
Clinical outcome surveys completed by healthcare professionals. Highest regulatory weight according to MDCG 2020-7.
NB AcceptedProspective
👤
Patient-Reported
Validated outcome measures (PROM/ePRO) licensed and scored according to developer specifications.
Licensed PROMPre-specified MCID
📊
Registry-Linked
Surveys coupled with national implant registry data (NJR, EPRD) for cross-validation over the long term.
NJR / EPRDLong Term
Understanding Surveys
What makes a PMCF survey valid under the MDR
A PMCF survey is a structured data collection instrument designed to fill gaps identified in your Clinical Evaluation Report (CER).
The word "survey" is often misleading. Level 4 surveys are methodologically equivalent to clinical investigations.
⚠️ Common Mistake
A survey without a pre-specified Statistical Analysis Plan (SAP) is not MDCG 2020-7 compliant. Post-hoc analysis is a frequent cause of non-compliance.
The Eclevar Difference
We start from the gaps in your PMCF Plan. Every instrument uses pre-specified endpoints, validated scales, and defined MCID thresholds before collection begins.
MDCG 2020-7 - ISO 14155:2020
Level 4 Requirements.
01. Validated Instrument
Scientific questionnaires with published psychometric properties. No marketing-style forms.
02. Pre-specified SAP
Sample size justification and MCID success criteria defined upfront.
03. Multi-Site Execution
Minimum of 3 to 5 sites with training and monitoring compliant with ISO 14155.
04. CER Traceability
Every objective must correspond to a specific residual risk from the evaluation report.
Tiered Solutions
Three Tiers of PMCF Surveys.
Gold Standard
High-Quality Level 4
The only tier acceptable for CER updates of Class IIb and III devices.
- Validated (EQ-5D, KOOS, etc.)
- Pre-specified SAP & MCID
- 3 to 15 clinical sites
- Ethics Committee Approval
Request Level 4 →
Clinician Surveys
Captures clinical performance and operator-reported outcomes (HCP).
- Targeted HCP populations
- Results-focused design
- Multi-country / Local languages
- 50 to 200 respondents
Patient Surveys
Licensed PROM instruments to collect functional outcome data.
- Full licensing agreements
- Pre-specified MCID
- GDPR Pseudonymization
- eCOA / ePRO Deployment
When to use a PMCF Survey
Four scenarios where a survey is the ideal instrument.
Device Families
When multiple variants require evidence simultaneously. Ideal strategy under MDR Article 61(2).
Long-Term Safety
Class III implants requiring 5 to 10 years of surveillance following initial trials.
Closing CER Gaps
Generate quality-of-life evidence within 4 to 8 months to meet recertification deadlines.
Real-World Evidence (RWE)
Capture experience in populations excluded from trials (elderly, comorbidities).
Platform Technology
MILO: Native Survey Deployment.
The MILO platform includes a native eCOA/ePRO module. Every response is timestamped, stored immutably, and exportable with a SHA-256 checksum for 21 CFR Part 11 compliance.
// SHA-256 DATA INTEGRITY LOCK
EXPORT_ID: ECV-S772-2026
STATUS: DATABASE_LOCKED
CHECKSUM: 4f8a92b1c3d...
AUDIT_TRAIL: COMPLIANT
Free · 30 Minutes · No Obligation
Your current CER should be the last
with a major non-compliance.
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
