… and Report your Post-Market Clinical Follow-up Evaluation!
- April 23, 2021
- Posted by: confinis
- Categories: confinis, Regulations
Last April, the Medical Device Coordination Group endorsed this guide for post-market clinical follow-up (PMCF) Evaluation Report addressed to manufacturers and notified bodies.
It contains two main useful information:
- a contextualization of the post-market clinical follow-up process with the link of the PMCF Evaluation Report to the clinical evaluation, the risk management documentation and the Summary of Safety and Clinical Performance (SSCP);
- a template for the PMCF Evaluation Report.
The results of the PMCF Evaluation Report shall be considered to update the clinical evaluation, the risk management documentation, the post market surveillance plan and the SSCP, if applicable.
The template reported in this guide for the PMCF Evaluation Report proposes seven sections. Three sections are particularly important: Section C, E and G.
In Section C, the manufacturer shall report all the Activities described in Section C of the PMCF plan which have been performed, all the collected clinical data obtained from those completed activities, as well as any justification of deviations from the plan with an analysis of the findings.
In Section E, the manufacturer shall discuss the aggregate results coming from each PMCF Activity, described in Section C, but also results coming from equivalent and/or similar device, described in Section D, which are considered to impact the technical documentation and at least the clinical evaluation report and the risk management file shall be considered.
In Section G, the manufacturer shall provide an overall conclusion of the findings. They should:
- be related to the aims of the PMCF plan;
- taken into account in the following clinical evaluation and in the risk management;
- highlight if any need for preventive and/or corrective measures has been identified;
- give input to the next PMCF plan.
In conclusion, we remind you about the need to report your Post-Market Clinical Follow-up Evaluation and we provided a short overview of the MDCG 2020-8 including the contextualization of the post-market clinical follow up process and the content of the PMCF Evaluation Report.
For the full details, please refer to the MDCG 2020-8.
If you have questions or need support, please contact us at info.ch@confinis.com.
This was the last blog of our series on novelties for the Clinical Evaluation and the Post Market Surveillance within MDR!
We hope you find useful this content, and we invite you to continue to follow us.
We will continue to talk about regulations, software and novel technologies such as AI in the medical field in our next blogs.
Authors: Dr. Martina Coscia, Dr. Andrea Biasiucci
Credits: the picture for this blog series has been inspired from a poster by R. Pradhan, S. Shrestha and U. Satyal entitled “Development of a digital tool for risk management, clinical evaluation and post-market surveillance of medical devices” for the 2020EuroConvergence conference.