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# Post-Market Clinical Follow-Up Report (PMCFR)

This template is used to document the results of all post-market-clinical-follow-up activities conducted for
the medical device.

## Product

| Product Name        | Version   |
| ------------------- | --------- |
| (your product name) | (version) |

## Context

> For your orientation, here is some guidance documents that may further help you to fill out the template:
> MEDDEV Guidance 2.7/1 Rev. 4 on Clinical Evaluation
> MEDDEV Guidance 2.12/2 Rev. 2 on Post-Market Clinical Follow-Up

The post-market clinical follow-up report (PMCFR) is compiled at the end of a surveillance interval as
specified in the post-market clinical follow-up plan (PMCFP) and serves as input for the next update of the
clinical evaluation. Following Annex XIV MDR, the PMCF is conducted 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.

## PMCF Objectives

> In this section, basically copy/paste the objectives from your PMCFP.

## PMCF Methods

> In this section, basically copy/paste the methods from your PMFCP.

## Analysis of Clinical Data

> Provide a list of your PMCF activity results. Ideally, divide it into sub-sections per actions taken and
> conclude if your objectives have been met.

### Implications for Clinical Evaluation

> Discuss if, based on the clinical data you gathered, your device delivered the anticipated benefits and
> fulfills the performance characteristics you claimed. For orientation: this refers to the 'References'
> section in your PMCFP.

### Implications for Risk Management

> Discuss if any new risks were identified or if deviations were observed regarding the assumed probability
> and severity of existing risks. Outline any risk mitigation measures that should be taken or revised.

| Risk | Measures | Responsible Role | Due DAte |
| ---- | -------- | ---------------- | -------- |
|      |          |                  |          |
|      |          |                  |          |

## PMCF Summary

> Highlight the most relevant results and conclusions from your PMCF activities. For example: does the
> clinical data suggest that the overall benefit-risk-profile of your product should be updated? If things
> look worse than before, why can it be assumed that your product is still safe?

## Update of Post-Market Clinical Follow-Up

> Describe implications for PMCF activities in the next surveillance interval.