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    Understanding PMPF Surveys for IVDR

    Post-Market Performance Follow-up (PMPF) surveys are essential for compliance with the In Vitro Diagnostic Regulation (IVDR). These surveys help manufacturers gather real-world data on the performance of their diagnostic devices after they have been placed on the market. PMPF surveys provide critical insights into the safety and efficacy of products, ensuring continuous monitoring and improvement. At Cetas Healthcare, we specialize in designing and conducting PMPF surveys that meet the stringent requirements of the IVDR, helping you maintain compliance and enhance product quality.

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      Our Approach to IVDR Compliance

      Cetas Healthcare takes a comprehensive approach to IVDR compliance. Our team of experts collaborates with you to develop a tailored PMPF survey strategy that aligns with your specific needs and regulatory requirements. We leverage our deep understanding of the IVDR framework to ensure that our surveys are thorough, accurate, and actionable. From initial planning to data collection and analysis, we handle every aspect of the PMPF process with precision and expertise, providing you with the insights needed to make informed decisions and maintain compliance.

      By choosing Cetas Healthcare as your partner, you gain access to:

      Proven Excellence

      Benefit from our extensive experience in the medical device industry and our successful track record in conducting PMPF surveys.
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      Regulatory Compliance

      Stay ahead of the game with our in-depth understanding of the IVDR framework, ensuring your products meet the necessary regulatory obligations.
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      Robust Data Analysis

      Leverage our expertise in data collection, analysis, and interpretation to derive meaningful insights that inform product enhancements and patient safety improvements.
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      Global Perspective

      Tap into our global network and understanding of regional requirements, enabling you to navigate the complexities of the international market.

      Collaborative Partnership

      Experience our commitment to building strong, long-lasting relationships with our clients, based on open communication, transparency, and trust.

      The Only Partner You'll Need From Conception to Completion

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      Design PMPF/PMPF Survey Plan

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      Real World Evicence / Data Collection

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      Analysis of Survey Data

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      PMPF Evaluation Report

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      See Our Clinical & Regulatory Services Portfolio Here

      Get Started with Your PMPF Survey Today

      Ensure your diagnostic devices remain compliant and perform optimally with Cetas Healthcare’s PMPF survey services. Our team is ready to assist you in navigating the complexities of IVDR compliance and providing the necessary support to achieve successful outcomes. Contact us today to learn more about how we can help you with your PMPF survey needs and take the first step towards enhanced regulatory compliance and product performance.

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      FAQs

      1. What is a PMPF Survey, and why is it important for IVDR compliance?

      A Post-Market Performance Follow-up (PMPF) survey is a critical component of the In Vitro Diagnostic Regulation (IVDR) framework in the EU. These surveys are designed to collect real-world evidence on the safety, performance, and clinical effectiveness of IVD devices after they have been launched on the market.

      Conducting a PMPF survey helps manufacturers:

      • Monitor the long-term performance of their diagnostic devices
      • Identify potential safety risks or performance issues early
      • Ensure continuous compliance with IVDR requirements
      • Make data-driven improvements to product quality and usability

      At Cetas Healthcare, we offer end-to-end PMPF survey services—from survey design and data collection to regulatory reporting—helping you maintain IVDR compliance while enhancing patient safety and product value.

      2. What is the difference between PMPF and PMS under IVDR?

      Under the IVDR, Post-Market Surveillance (PMS) refers to the comprehensive system manufacturers implement to monitor the safety and performance of in vitro diagnostic (IVD) devices after they have been placed on the market. This includes collecting and analyzing
      data from various sources to ensure ongoing compliance and patient safety.

      Post-Market Performance Follow-up (PMPF) is a subset of PMS, focusing specifically on proactively collecting and evaluating data to confirm the scientific validity, analytical, and clinical performance of an IVD device throughout its lifecycle. PMPF activities are designed to identify any emerging risks or performance issues that may not have been apparent during the initial conformity assessment.

      3. Is a PMPF plan mandatory for all IVD devices under IVDR?

      Yes, the IVDR mandates that manufacturers develop and implement a PMPF plan for all IVD devices. This plan should outline the methods and procedures for proactively collecting and evaluating data on the device's performance post-market. However, if a manufacturer determines that PMPF is not necessary for a particular device, this decision must be duly justified and documented within the technical documentation.

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