This template is intended for documenting the outcomes of post-market clinical follow-up (PMCF) activities for the [name of the medical device].
Note:
As per MDR, Annex XIV, Part B (7), the manufacturer is required to analyze the PMCF findings and document them in a PMCF evaluation report, which should be included in both the clinical evaluation report (CER) and the technical documentation.
This means you may use this template or enter the results directly into the CER.
Product Information
| Parameter | Description |
|---|---|
| Product or trade name: | |
| Model and type: | |
| Intended purpose: |
Context
For further guidance, refer to the following document to aid in completing the template:
- MDCG 2020-8: Post-market clinical follow-up (PMCF) Report Template: A guide for manufacturers and notified bodies
The PMCF report (PMCFR) is compiled at the end of a surveillance period defined in the PMCF plan (PMCFP) and serves as a contribution to the next clinical evaluation update. As outlined in Annex XIV MDR, PMCF activities aim to:
- Verify the safety and performance of the device throughout its lifecycle,
- Detect previously unknown side effects and monitor known side effects and contraindications,
- Identify and analyze emerging risks based on real evidence,
- Ensure the benefit-risk ratio remains acceptable, as outlined in sections 1 and 9 of Annex I MDR,
- Identify potential systematic misuse or off-label use of the device to validate its intended use.
1. PMCF Activities: General and Specific Methods and Procedures
This section should detail all activities described in the PMCF plan that have been completed, the clinical data collected, and any justification for deviations from the plan.
The discussion should include an analysis of the findings, whether positive or negative, and their potential impact on various documents (e.g., CER, risk management file, SSCP) reviewed during the conformity assessment.
Each performed activity should be described in separate subsections based on the type of activity (e.g., device registry, PMCF studies, real-world evidence, surveys on device use). Each subsection should also include details on the quality of the collected data.
1.1 General Methods and Procedures
Summarize the PMCF activities outlined in section 1.1 of the PMCF plan.
1.2 Specific Methods and Procedures
Summarize the PMCF activities outlined in section 1.2 of the PMCF plan.
2. Clinical Data Evaluation of Equivalent or Similar Devices
This section should report all clinical data collected regarding an equivalent or similar device(s), analyze and summarize the results, and discuss if any changes in the state of the art or new hazards affect the device’s benefit-risk determination, the CER, and/or the PMCF plan.
| Equivalent/ Similar Device Name | Results Discussion | References (e.g., publications, technical documentation) |
|---|---|---|
3. Impact of Findings on Technical Documentation
This section should include an analysis of the combined results from each planned PMCF activity (as described in section C), as well as data from equivalent or similar devices (section D), to determine any impact on technical documentation. The analysis should address at least the following documents:
3.1 Clinical Evaluation Report (CER) – (date and version)
- No relevant data from the CER were considered.
If applicable, the manufacturer should explain why information that might affect the CER was not included.
Relevant information analyzed and monitored:
- Include details here
This analysis should be reflected in the updated CER.
3.2 Risk Management File – (date and version)
- No relevant data from the risk management file were considered.
If applicable, the manufacturer should explain why information that might affect the risk management file was not included.
Relevant information analyzed and monitored:
- Include details here
4. Conclusions
The manufacturer should provide an overall conclusion of the findings, relating them to the PMCF plan’s objectives. The conclusions should be factored into the next clinical evaluation and risk management updates. Any need for preventive or corrective actions should be highlighted, as well as input for future PMCF plans.
5. Updates to Post-Market Clinical Follow-Up
Outline any implications for future PMCF activities for the next surveillance period.