Post-Market Clinical Follow-Up (PMCF)

MDR Reference: Annex XIV, Part B; Article 61(11)
BPG Rev.4 Reference: Section 6.3.4 (pp. 81-84)
Document Code: AII-S6-PMCF
Responsible Party: CRO
Service Mode: Write / Assist

PMCF Plan

Requirements Checklist

• [ ] Device scope and identification (Basic UDI-DI, variants covered)
• [ ] Objectives and rationale for PMCF activities
• [ ] Methodology differentiation between general and specific PMCF methods
• [ ] Justification for chosen methods and for not performing specific PMCF (if applicable)
• [ ] Sample size justification (statistical basis for specific activities)
• [ ] Timeline and milestones
• [ ] Responsible parties identified
• [ ] Data analysis plan

General PMCF Methods (Annex XIV Part B, 6.2)

General methods are applicable to all device types:

• [ ] Systematic literature review (ongoing, post-market)
• [ ] Solicited user feedback / focus groups
• [ ] Review of regulatory device databases (EUDAMED, MAUDE, etc.)
• [ ] Level 8 surveys (recall of multiple device usages)

General PMCF is particularly suited when:

• Long-term safety and performance are known / device is standard of care
• Long market history with no identified trends or safety concerns
• Sufficient quality and quantity of clinical data supports claims

Specific PMCF Methods (Annex XIV Part B, 6.2)

Specific methods are required when uncertainties remain from clinical evaluation:

• [ ] Retrospective/prospective clinical studies (PMCF studies)
• [ ] Registry studies (national/population-level registries)
• [ ] Real-world data (RWD) studies
• [ ] Level 4 high-quality surveys (one questionnaire per patient chart/device use)
  • [ ] Validated questionnaire
  • [ ] Statistically calculated sample size
  • [ ] Clearly defined primary and secondary endpoints

Specific PMCF is usually required for:

• Novel technologies or new/novel intended use
• Higher-risk devices and use scenarios
• Devices approved with equivalent device clinical data
• Urgent market access in public health emergencies
• Open questions from clinical evaluation (e.g. long-term implant lifetime)

Changes to PMCF Plan

• [ ] Change management process for significant PMCF plan changes
• [ ] NB notification for significant changes prior to implementation
• [ ] Significant changes include: removal/ceasing of activities, delays, sample size reduction, changes to objectives/endpoints/SAP

PMCF Evaluation Report

Requirements Checklist

• [ ] Results of all general PMCF activities (presented separately)
• [ ] Results of all specific PMCF activities (presented separately with rationale, sample size, objectives)
• [ ] Analysis of results against PMCF Plan objectives
• [ ] Impact on benefit-risk assessment
• [ ] Conclusions and recommendations for CER update
• [ ] Alignment with PMS report/PSUR conclusions
• [ ] Can be standalone document or included in CER

Key Regulatory References

• MDR (EU) 2017/745, Annex XIV, Part B
• MDR (EU) 2017/745, Article 61(11)
• MDCG 2020-7: PMCF plan and evaluation report templates
• MDCG 2020-8: PMCF evaluation report template
• MDCG 2020-6: Sufficient clinical evidence (PMCF integration)
• EN ISO 14155: Clinical investigation of medical devices for human subjects
• Team-NB BPG for TD Submission, Rev.4 (2026-04-21), Section 6.3.4

Common Pitfalls (from BPG Rev.4)

• PMCF plan not clearly differentiating general vs specific activities
• No justification for not performing specific PMCF when appropriate
• General PMCF presented without clear objectives or systematic approach
• PMCF study objectives/endpoints inconsistent with clinical evaluation
• Specific PMCF activities not conducted in EU countries without justification
• Significant PMCF plan changes not communicated to NB

Dependency

PMCF is a Phase 3 deliverable (Plan) and Phase 5 deliverable (Report):

• PMCF Plan depends on CEP (evaluation strategy) and CER (identified gaps/uncertainties)
• PMCF Report feeds back into CER updates and PSUR
• PMCF Plan is required for all device classes
• PMCF Report is required when available (may not exist at initial certification)