Description:
This Post-Market Clinical Follow-Up Plan sets a controlled way to define, run, and document PMCF activities that keep clinical evidence current across the device lifecycle.

• Define controlled identifiers (PMCFP-ZZZZ rev.Y, approvals, revision history, dates).

• Record manufacturer contacts including SRN and PRRC details.

• Describe the device and scope (Basic UDI-DI, EMDN, class/rule, expected lifetime, intended purpose).

• Plan PMCF activities with objectives, rationale, limitations, and timelines (Table 4).

• Specify general methods: literature search and vigilance/recall screening with named databases.

• Specify specific methods where needed: device registry, PMCF investigation, patient/user survey with protocol essentials.

• Link PMCF to CER and risk management outputs (Tables 5–6) and include similar/equivalent device evaluation (Table 7).

• Reference applicable guidance (MDCG 2020-7, MDCG 2020-8) and define the PMCF evaluation report date.

Your needs:

• PMCF plan template

• PMCF plan template for MDR compliance

• Reduce rework, tighten clinical evidence updates, and improve NB review readiness.

Use this template when drafting or updating PMCF planning to ensure PMCF activities, timelines, and evidence links remain consistent with your clinical evaluation and risk management approach.

It clarifies what to collect and why. PMCF activities are planned methods to confirm safety/performance and detect emergent risks. Equivalent/similar device evaluation extends monitoring to comparable technologies to support state-of-the-art alignment.

• Control document approval, revision, and traceable identifiers.

• Define device scope and intended purpose inputs from IFU/TD/CER.

• Plan literature and vigilance/recall screening with databases and limitations.

• Define study-like methods (registry/investigation/surveys) with endpoints and approvals.

• Capture CER and risk file gaps/risks to be followed up.

• Set collection, analysis, and reporting timelines aligned to PMS planning.

At Lexqara, we develop PMCF plans and evaluation pathways that integrate clinical documentation, PMS signals, and risk management updates—built for audit and submission workflows. Resource Center [https://lexqara.com/resource-center] and Clinical Documentation support [https://lexqara.com/services/clinical-documentation]. MDCG 2020-7 guidance [https://health.ec.europa.eu/system/files/2020-06/mdcg_2020_7_guidance_on_pmc_plan_template_en_0.pdf]. Download the template or request a short gap assessment.