This article describes how to prepare the PMS & PMCF report and why is it necessary.

1. PMS AND PMCF REPORT
SAKTHISRI
I 3 Consulting
sri@i3cglobal.com

2. PMS Report
Post market surveillance (PMS) report plays a vital role in determining the post-market
clinical performance and safety of the medical device. A proper plan and report should be
maintained by the organization for conducting the post market surveillance.
Achievements of PMS system shall include the following:
• Detection of manufacturing problems
• Product quality improvement
• Confirmation of risk analysis
• Knowledge of long term performance or complications
• Customer satisfaction
• Performance in different user populations etc.
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3. PMS Report
Based on the post market surveillance through Feed backs, Customer complaints,
Regulatory reports, literature review, Failure analysis and In house testing, an annual
report is prepared which is communicated annually through the management review
meetings. Based on the report conclusion, additional precautions can be taken by the
organization or can be included in Risk management process or design changes and the
same can be submitted to Notified Body auditors.
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4. PMCF Report
Post Market Clinical Follow Up (PMCF) report plays a vital role in determining the post-market
clinical performance and safety of the medical device. A proper plan and report should be
maintained by the organization for conducting the PMCF. PMCF is the activity of monitoring the
safety of Medical devices after it has been released on the Market. PMCF uses a number of
approaches to monitor the safety of Medical device, including spontaneous reporting databases.
These data are reviewed to highlight potential safety concerns in the process. Through its
premarket review process and Post market clinical follow up studies assure that the risk
associated with Medical device have been minimized when those device first enters into the
market.
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5. PMCF Report
The PMCF study and report should be
• Executed with adequate control measures to assure compliance with the study plan;
• Include data analysis with conclusions drawn according to the analysis plan by someone with
appropriate expertise; and
• Have a final report with conclusions relating back to original objectives.
The conclusions derived from PMCF studies according to MEDDEV 2.12/2 Rev.2 are used to provide
the clinical evidence for clinical evaluation, to reassess the device comply with the essential
requirements. Based on PMCF study corrective and preventive actions can be implemented if
necessary and the same can be submitted to Notified Body auditors.
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