Description:
This PMCF Evaluation Report template documents post-market clinical follow-up results to keep clinical evidence current and confirm ongoing safety, performance, and benefit-risk acceptability.

• Control identifiers (PMCFR-ZZZZ rev.Y), Approval, and Revision history.

• Record manufacturer and SRN details, including PRRC contact information.

• Confirm PMCF objectives (safety, performance, side-effects, emergent risks, benefit-risk, misuse/off-label).

• Document literature search using PICO, named databases, and Level-1/Level-2 screening.

• Appraise clinical data using MDCG 2020-6 Rank and Oxford LoE.

• Perform vigilance/recall screening (e.g., FDA MAUDE, recalls, national FSCA databases) and summarize risks.

• Complete Impact assessment on Risk Management, Clinical Evaluation, PMS, SSCP, and CAPA/FSCA need.

Your needs:

• PMCF evaluation report

• PMCF evaluation report for MDR compliance

• Reduce rework, strengthen defensibility, and speed up notified body reviews.

Use this report after executing your PMCF plan to aggregate post-market clinical data and document its impact on the CER, risk management file, and PMS outputs.

It covers key technical expectations. PICO structures search questions to retrieve relevant clinical evidence. MDCG ranking supports consistent appraisal and transparency of data quality.

• Define the PMCF activity period and justify any deviations.

• Document databases, queries, and screening decisions.

• Summarize safety/performance outcomes and clinical risks.

• Record event rates and identify new vs existing risks.

• Conclude impacts on CER, risk management, PMS, SSCP, and CAPA.

At Lexqara, we build PMCF evaluation reports, literature/vigilance search packages, and impact assessments aligned to your clinical documentation and PMS workflows. Resource Center [https://lexqara.com/resource-center] and Clinical Documentation support [https://lexqara.com/services/clinical-documentation]. MDCG 2020-8 guidance [https://health.ec.europa.eu/system/files/2020-06/mdcg_2020_8_guidance_on_pmc_eval_report_template_en_0.pdf]. Download the template or request a short gap assessment.