Pressure-Test Your Survey Design Before Notified Bodies Do
Under EU MDR, a PMCF survey is a clinical evidence instrument. Notified bodies routinely reject surveys that fail to qualify as Level 4 evidence, defaulting them to Level 8 “general feedback” status. The results are deficiency letters, costly rework, and delayed market access.
This checklist helps you evaluate whether your PMCF survey is designed to generate scientifically valid clinical evidence that can withstand regulatory scrutiny.
What You’ll Get:
- Objectives & strategy: Are your survey endpoints mapped directly to your PMCF Plan and CER? Have you justified why Level 4 evidence is sufficient for your device class?
- Scientific validity: Does your survey include documented methodology, sample size rationale, and measures to minimize recall and sampling bias?
- Safety & adverse event handling: Is there a compliant pathway for respondents to report AEs, supported by an internal triage SOP?
- Documentation & traceability: Does your final report link findings directly to protocol objectives and clinical claims? Does your documentation reference MDCG 2020-6, -7, and -8?1–3
Who Should Download:
- Clinical affairs and regulatory leaders managing PMCF obligations
- Teams preparing for notified body technical documentation reviews
- Quality and RA managers addressing PMCF deficiency findings
Download the PMCF survey checklist to identify gaps before your next submission and move from feedback-grade data to decision-grade evidence.
References
1 Medical Device Coordination Group Document. (2020). MDCG 2020-6: Regulation (EU) 2017/745: Clinical evidence needed for medical devices previously CE marked under Directives 93/42/EEC or 90/385/EEC. https://health.ec.europa.eu/system/files/2020-09/md_mdcg_2020_6_guidance_sufficient_clinical_evidence_en_0.pdf
2 Medical Device Coordination Group Document. (2020). MDCG 2020-7: Post-market clinical follow-up (PMCF) Plan Template. A guide for manufacturers and notified bodies. https://health.ec.europa.eu/system/files/2020-09/md_mdcg_2020_7_guidance_pmcf_plan_template_en_0.pdf
3 Medical Device Coordination Group. (2020). MDCG 2020-8: Post-market clinical follow-up (PMCF) Evaluation Report Template. A guide for manufacturers and notified bodies.
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