Post-Market Clinical Follow-Up Plan (PMCFP)

This document is used to plan all post-market clinical follow-up activities for the <name of the medical
device].

Product information

Context

Check out this guidance document which may further help you to fill out the template: MDCG 2020-7
Post-market clinical follow-up (PMCF) Plan Template: A guide for manufacturers and notified bodies

The post-market clinical follow-up plan is compiled along with concluding the clinical evaluation and is based
on the clinical evaluation report. Following Annex XIV MDR, it specifies the methods used to collect and
evaluate clinical data with the aim of:

• confirming the safety and performance of the device throughout its product life cycle,
• identifying previously unknown side-effects and monitoring the identified side-effects and contraindications,
• identifying and analyzing emergent risks on the basis of factual evidence,
• ensuring the continued acceptability of the benefit-risk ratio referred to in sections 1 and 9 of annex I MDR, and
• identifying possible systematic misuse or off-label use of the device, with a view to verifying that the intended purpose is correct.

1. Activities related to PMCF: general and specific methods and procedures

This section outlines post-market activities for PMCF, detailing general and specific methods/procedures
related to the product's scope. It also covers the purpose of each activity, the rationale behind chosen
methods, and anticipated limitations. Activity timelines are to be defined quarterly or yearly.

Examples of PMCF activities include:

1. Manufacturer Device Registry: Specific to the device type or medical device group, include a brief plan description, specifying quality and quantity data based on device risk.
2. PMCF Studies: Details study plans, encompassing design, sample size, endpoints, and inclusion/exclusion criteria.
3. Surveys: Describes planned surveys for collecting information on the use of the medical device.

The overarching aim is to streamline post-market activities, ensuring comprehensive data collection,
analysis, and validation.

1.1 General methods and procedures

According to the MDR, Annex XIV, 6.2 The PMCF plan shall include at least:

(a) the general methods and procedures of the PMCF to be applied, such as gathering of clinical experience
gained, feedback from users, screening of scientific literature and of other sources of clinical data;

Below are two examples provided:

1.2 Specific methods and procedures

According to the MDR, Annex XIV, 6.2 The PMCF plan shall include at least:
(b) the specific methods and procedures of PMCF to be applied, such as evaluation of suitable registers or PMCF studies;

2. Reference to the relevant parts of the technical documentation

In this segment, the manufacturer must incorporate citations to pertinent details from both the clinical
evaluation report and the risk management file. These references are subject to analysis, follow-up, and
assessment within this plan. Alternatively, the manufacturer must explicitly declare if there is no relevant
information from the clinical evaluation report and/or the risk management file that requires consideration
in this plan.

2.1 Clinical Evaluation Report (date and version)

Relevant information to be further analysed and monitored:

• <Describe what needs to be analysed>

Example: The clinical data gathered and evaluated as a result of this PMCF plan will be used to update and
verify the chapters 11.6 (literature summary and conclusion), 12 (clinical experience data), 13
(risk-benefit assessment) and the conclusion of the CER. The literature will furthermore be searched for
similar devices with a focus on associated risks and the state of the art.

• No relevant information from the clinical evaluation report to be considered in this plan

2.2 Risk Management File (date and version)

Relevant information to be further analysed and monitored:

• <Describe what needs to be analysed>

Example: Clinical data will be used to ensure the ongoing appropriateness of identified hazards, hazardous
situations, harms, their frequency and severity estimations in the risk assessment & risk
control. Furthermore, the data including information on similar devices shall be evaluated to identify
potential emerging risks in the risk assessment & risk control.

• No relevant information from the risk management file to be considered in this plan

3. Evaluation of clinical data relating to equivalent or similar devices

In this section, the manufacturer is required to compile information on equivalent or similar devices, the
clinical data of which will be subsequently assessed and presented in the PMCF report. It is important to
highlight that PMCF data, aimed at demonstrating ongoing safety and performance, should primarily originate
from the specific device under evaluation. While data from equivalent or similar devices may be utilized—for
instance, to update information on the state of the art or to identify and further evaluate relevant safety
outcomes—the selected devices must remain consistent throughout the technical documentation. It is essential
to specify whether the chosen device is confirmed to be equivalent or is categorized as a similar
device. Each listed device should include a clear reference to the relevant sections of the Clinical
Evaluation Report (CER).

The following equivalent or similar devices have been chosen and the clinical data will subsequently assessed:

4. PMCF evaluation report

The findings of the PMCF will be summarized in the PMCF Evaluation Report that is part of the clinical
evaluation report and the technical documentation.

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