Template: Post-Market Clinical Follow-Up Plan (PMCFP)

This document outlines the planning of all post-market clinical follow-up activities for the [name of the medical device].

Product Information

Parameter	Description
Product or trade name:
Model and type:
Intended purpose:

Context

For additional guidance, refer to MDCG 2020-7: Post-market clinical follow-up (PMCF) Plan Template, which provides helpful insights for completing this document.

The PMCF plan is developed after the clinical evaluation and is based on the clinical evaluation report. As outlined in Annex XIV MDR, this plan describes the methods used for collecting and analyzing clinical data to achieve the following:

• Confirming the safety and effectiveness of the device throughout its lifecycle,
• Detecting previously unidentified side effects and monitoring known side effects and contraindications,
• Identifying and analyzing emerging risks based on evidence,
• Ensuring that the benefit-risk balance remains acceptable, as detailed in sections 1 and 9 of Annex I MDR,
• Identifying potential misuse or off-label use of the device to verify the accuracy of its intended purpose.

1. PMCF Activities: General and Specific Methods and Procedures

This section details post-market activities for PMCF, outlining general and specific methods and procedures related to the product’s scope. Each activity’s purpose, rationale, and expected limitations should be included, with timelines defined on a quarterly or annual basis.

Examples of PMCF activities include:

1. Manufacturer Device Registry: Tailored to the device type or group, include a brief plan description with quality and quantity data relevant to device risk.
2. PMCF Studies: Outline study plans, including design, sample size, endpoints, and inclusion/exclusion criteria.
3. Surveys: Detail surveys designed for collecting user feedback on device use.

The primary goal is to facilitate comprehensive data collection, analysis, and validation for post-market activities.

1.1 General Methods and Procedures

In accordance with MDR Annex XIV, 6.2, the PMCF plan must include the general methods and procedures, such as gathering clinical experience, user feedback, and reviewing scientific literature and other clinical data sources.

Examples:

Method 1
Description:
Search period:
Objective:
Search Strategy:
Rationale and known limitations of the activity:

Method 2
Description:
Search period:
Objective:
Additional information
Rationale and known limitations of the activity:

1.2 Specific Methods and Procedures

In line with MDR Annex XIV, 6.2, the PMCF plan must detail specific methods and procedures, such as evaluating suitable registries or conducting PMCF studies.

Method 3
Description:
Search period:
Objective:
Additional information
Rationale and known limitations of the activity:

Method 4
Description:
Search period:
Objective:
Search Strategy:
Rationale and known limitations of the activity:

2. Reference to Relevant Parts of the Technical Documentation

This section should include references to pertinent information from the clinical evaluation report and risk management file. If there is no relevant data to consider, the manufacturer must clearly state this.

2.1 Clinical Evaluation Report (date and version)

Relevant information for further analysis and monitoring:

Example: Data collected and assessed from this PMCF plan will be utilized to update and verify sections 11.6 (literature summary and conclusion), 12 (clinical experience data), 13 (risk-benefit assessment), and the conclusion of the CER. The literature will also be searched for similar devices to assess associated risks and the current state of the art.

• No relevant data from the clinical evaluation report to be incorporated in this plan.

2.2 Risk Management File (date and version)

Relevant information for further analysis and monitoring:

Example: Clinical data will be used to ensure the relevance of identified hazards, their frequency, severity, and any necessary risk control updates. Additionally, data on similar devices will be reviewed to identify emerging risks.

• No relevant data from the risk management file to be incorporated in this plan.

3. Clinical Data Assessment of Equivalent or Similar Devices

The manufacturer must compile information on equivalent or similar devices, which will be assessed and included in the PMCF report. PMCF data should primarily focus on the specific device being evaluated, though data from similar devices may be used to update the state of the art or assess relevant safety outcomes. Consistency across technical documentation is crucial, and it must be clear if a device is equivalent or similar. Each device referenced should link back to relevant CER sections.

Parameter	Equivalent / similar device 1	Equivalent / similar device 2
Product name of equivalent / similar device
Intended purpose
Intended users
Intended patient population
Medical condition
Indication
Reference to clinical data evaluation in the CER (date, version, and section)

4. PMCF Evaluation Report

The outcomes of the PMCF activities will be summarized in the PMCF Evaluation Report, which is part of both the clinical evaluation report and the technical documentation.

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