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With the introduction of the Medical Device Regulation (MDR), the requirements for placing medical devices on the market have significantly increased. Additional manufacturers’ obligations concerning post-market surveillance (PMS), including post-market clinical follow-up (PMCF), have gained importance.
Under the MDR, PMCF expectations include specific requirements, such as the need for a PMCF plan, specifying the methods and procedures for clinical data collection, and clearly stated objectives for PMCF activities for devices of all risk classes.
In this blog post, we will explore what PMS and, more specifically, PMCF entail and why they are vital for both manufacturers and users of medical devices.
Understanding PMS and PMCF under the MDR
PMS is a comprehensive process that manufacturers must establish to collect and review experiences gained from the medical devices they have placed on the market. The primary aim is to ensure that any potential safety issue is identified and assessed promptly, guaranteeing the continuous improvement of the device’s safety and performance.
PMCF is a component of the overall PMS. PMCF activities involve systematically and continuously collecting and analyzing real-world clinical data to confirm the safety and performance of the device throughout its entire lifetime. This ensures the acceptability of known risks and helps detect emerging risks or unforeseen adverse events.
Through PMS and PMCF, manufacturers can:
Various types of PMCF activities
Several types of PMCF activities can be undertaken by the manufacturer to gather post-market clinical data. Each type has its strengths and limitations, and the choice should be based on a thorough gap analysis of the existing clinical data.
This analysis should determine if the data cover the device’s lifetime, are sufficient in quantity and quality, support each claimed clinical benefit, and comply with current quality and ethical standards.
If any gaps are identified, PMCF activities should be planned. Usually, a combination of multiple PMCF activities is recommended to gather sufficient clinical data to support the MDR requirements.
How can we assist you during the post-market stage of your medical device?
QbD Regulatory can help you to prepare the Technical Documentation, including risk management and post-market surveillance documents.
QbD Clinical Medical Writing specializes in performing the required Clinical Evaluation for your device, including addressing the possible gaps in clinical evidence for your device in scope. This involves reviewing and analyzing all necessary literature and writing the clinical evaluation plan and report.
Further gaps in clinical evidence can be handled by setting up the right PMCF activities, by writing the proper PMCF plan, including the defined activities to collect more clinical data on the safety and performance of the device under evaluation to eventually produce a PMCF report and, hence an updated clinical evaluation report in due time. These documents are created following all applicable guidance and regulations.
QbD Clinical Operations handles PMCF investigations from setup to execution and data analysis. Don’t hesitate to reach out to us for assistance, whether it is coaching, reviewing, or fully writing your technical documentation as required.
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