PMCF Plan Template: How to Structure Objectives, Methods, Endpoints, Timeline, and Reports

Why a PMCF Plan Template Matters

Post-Market Clinical Follow-Up (PMCF) is a continuous process that updates the clinical evaluation and shall be addressed in the manufacturer's post-market surveillance (PMS) plan. Under EU MDR Article 61 and Annex XIV Part B, PMCF is not optional for most device classes — especially Class IIa, IIb, and III devices, and all implantable devices.

Notified Bodies increasingly issue nonconformities when PMCF plans lack traceability to clinical evaluation gaps, when objectives are vague, or when methods are not justified. This template provides a section-by-section structure aligned with MDCG 2020-7 and practical implementation guidance that goes beyond the template itself.

This is a template and implementation guide — not a general overview of PMCF. For the regulatory framework and strategy, see the companion PMCF guide.

PMCF Plan Structure Per MDCG 2020-7

Section A: Manufacturer Contact Details

Revision history table:

Section B: Device Description and Specification

Section C: PMCF Activities

This is the core of the PMCF Plan. It must include both general and specific methods, the aim of each activity, the rationale for appropriateness, and known limitations.

General Methods (Annex XIV Part B, 6.2(a))

Specific Methods (Annex XIV Part B, 6.2(b))

Activity Description Template

For each PMCF activity, document the following:

Section D: References to Relevant Parts of Technical Documentation

Section E: Evaluation of Clinical Data for Equivalent or Similar Devices

This section requires an assessment of whether clinical data from equivalent or similar devices informs the PMCF strategy.

Section F: Reference to Applicable Common Specifications, Harmonised Standards, and Guidance Documents

Section G: Estimated Date of PMCF Evaluation Report

Deriving PMCF Objectives from CER Gaps

The most common Notified Body nonconformity in 2026 is PMCF plans that do not trace back to specific clinical evaluation gaps. Use this structured approach:

Example: CER Gap to PMCF Objective Traceability

Defining Endpoints and Sample Size

Endpoint Types for PMCF

Sample Size Logic

PMCF does not always require formal statistical powering. Justify sample size based on:

PMCF Schedule Template

PMCF Evaluation Report Structure (MDCG 2020-8)

The PMCF Evaluation Report mirrors the PMCF Plan structure with results filled in:

Acceptance Criteria Evaluation Template

Integration with PMS, Risk Management, and PSUR

PMCF does not exist in isolation. The following traceability chain is now expected by Notified Bodies:

Clinical Evaluation (CER)
    → identifies gaps/residual uncertainties
        → PMCF Plan addresses gaps
            → PMCF Evaluation Report analyzes results
                → Updated CER integrates findings
                    → Risk Management File updated
                        → PSUR summarizes benefit-risk
                            → PMS Plan triggers next cycle

Common 2026 Audit Deficiencies

Key Takeaways

• Structure the PMCF Plan using the seven-section MDCG 2020-7 template as a baseline, but add the device-specific depth that Notified Bodies expect in 2026

• Derive every PMCF objective from a documented gap or residual uncertainty in the Clinical Evaluation Report — this is the most scrutinized element

• Select PMCF methods proportionate to device risk and justify why each method is appropriate

• Define specific, measurable acceptance criteria for every objective — vague statements like "confirm safety" will trigger nonconformities

• Build the PMCF Evaluation Report structure before collecting data, so the analysis plan is pre-specified

• Maintain bidirectional traceability: CER → PMCF Plan → PMCF Report → updated CER → Risk File → PSUR

• Submit the first PMCF results to your Notified Body during the first surveillance audit after CE marking — delays signal noncompliance