What is a PMCF report and what must it contain?

The PMCF report documents continuous clinical follow-up following marketing and is a central component for the continuous update of clinical evaluation in accordance with MDR.

1 Legal framework

Regulation (EU) 2017/745 (MDR) regulates the post-marketing clinical follow-up (Post-Market Clinical Follow-Up, PMCF) as part of a manufacturer's post-market surveillance system (Art. 61, Art. 83 ff., Annex XIV Part B). With its MDCG 2020-8 guideline, the Medical Device Coordination Group (MDCG) clarifies the formal and content structure of PMCF evaluation reports.

2 Purpose of the PMCF report

The PMCF report

• Constantly confirms that Safety, performance, and clinical benefits the product is retained for the entire expected lifetime,
• identifies new risks, side effects and off-label applications early,
• provides evidence for Maintaining a positive benefit-risk balance and
• Feeds the results in clinical evaluation, risk management file, PMS plan and SSCP one (Art. 86 MDR).

3 MDCG 2020-8 structure

1. Section A — Manufacturer Information
 legally binding contact details, SRN, Person Responsible for Regulatory Compliance (PRRC), authorized representative, if applicable.

2nd Section B — Device description
Product name, basic UDI-DI, class, classification rule, purpose, patient target group, expected lifespan, etc.

3rd Section C — PMCF activities carried out
For each activity (e.g. registries, PMCF studies, real-world evidence, user surveys),

· data collection,

· data quality,

· deviations from the plan and

· Explain results in detail.

4th Section D — Data on similar or similar products
Summary of external clinical data, analysis of state-of-the-art developments and their impact on benefit-risk.

5th Section E — Implications for Technical Documentation
Explain how results change or confirm individual documents (clinical evaluation report, CER), risk management file (risk management file, RM file), PMS plan and summary of safety and clinical performance (SSCP)).

6th Section F — References to standards and specifications
Verification of whether data compliance is applied Common specifications, harmonised standards or guidelines continue to exist.

7. Section G — Overall Conclusion
Consolidation of all findings, comparison with PMCF goals, definition of preventive or corrective measures and impulses for the next PMCF plan.

‍

4 Creation and maintenance

• data sources must be selected proactively, systematically and — where possible — prospective (e.g. registers instead of individual case reports).
• data quality Is after MEDDEV 2.7/1 rev. 4 (chapter 9.3.1) to evaluate (relevance, completeness, distortion).
• frequency: Annual for implantable and class III devices; risk-based for lower classes in accordance with the PMS plan.
• variances The PMCF plan must be justified and evaluated, as they may influence the significance of the report.

5 Common Pitfalls

• Incomplete documentation of data origin and quality.
• Failure to link results with risk management and CER.
• Overestimation of passive data sources (vigilance reports) without proactive data collection.
• Incomprehensible reason for a “PMCF waiver” for existing products.

6 best practice recommendations (MDCG 2020-8)

• Use sample document consistently — facilitates audit and audit by a notified body.
• Establish traceability — every statement in the report must be based on clearly referenced data.
• Living document — update after every new evidence (e.g. publication, registry update).
• Increase synergies — Combine PMCF studies with post-market performance follow-up (PMPF) when IVD components are affected, for example.

7 Checklist for manufacturers

• PMCF plan created and approved on a risk-based basis?
• Addressed all objectives required in Part B of Annex XIV?
• Complete evaluation of all planned activities?
• Effects on CER, RM file, SSCP demonstrably documented?
• Preventive/corrective measures introduced and enshrined in the PMS report?

‍

The experts from MEDIACC will be happy to answer any questions you may have about practical implementation or the preparation of a compliant PMCF report. Feel free to arrange a first non-binding appointment with us!

‍

‍

Source: htt ps: //healt h.ec.euro pa.eu/system/files/2020-0 9/md_mdcg_2020_8_guidance_pmcf_evaluation_report_en_0.pdf (delete space for link)