Description:
This Post-Market Clinical Follow-Up (PMCF) Procedure defines how we proactively collect clinical data after CE marking to keep the clinical evaluation current and confirm ongoing safety, performance, and benefit-risk acceptability.

• Define PMCF objectives to confirm safety/performance over expected lifetime and detect new side-effects.

• Link PMCF to PMS, CER/CEP, risk management, and CAPA decision-making.

• Use controlled records: FORM-PMS-004 PMCF plan and FORM-PMS-005 PMCF evaluation report with defined IDs.

• Apply grouping of devices consistent with the CEP/CER grouping rationale.

• Specify PMCF methods, including literature search, vigilance & recall search, and user feedback.

• Define update frequencies, including annual updates for class III/implantable devices.

Your needs:

• PMCF procedure

• PMCF procedure for MDR decision-making

• Reduce rework, strengthen clinical evidence updates, and improve inspection readiness.

This procedure is used when planning and running PMCF to proactively generate clinical evidence and feed updates into the CER, PMS reporting, and risk management activities.

It clarifies critical terms. PMCF is proactive clinical data collection post-market; it matters because it keeps the benefit-risk ratio current. RWE is real-world evidence from routine use; it matters because it can reveal emergent risks.

• Define PMCF plan methods, rationale, objectives, and schedule milestones.

• Document general PMCF activities (literature, vigilance/recall, user feedback).

• Define specific PMCF activities (surveys, registries, PMCF studies) with protocol essentials.

• Analyze findings in a PMCF evaluation report and link impacts to CER/risk/CAPA.

• Control approvals and retention per document and record control.

At Lexqara, we build PMCF plans and evaluation reports that integrate with PMS, clinical documentation, and regulatory strategy, with training and audit support. Resource Center [https://lexqara.com/resource-center] and Post-Market Surveillance support [https://lexqara.com/services/post-market-surveillance]. MDCG 2020-7 (PMCF plan template guidance) [https://health.ec.europa.eu/system/files/2020-06/mdcg_2020_7_guidance_on_pmc_plan_template_en_0.pdf]. Request a short gap assessment.