What is Post Market Performance Follow-up
Post Market Performance Follow-up (PMPF) is a new term which appears in EU IVDR 2017/746, what does it mean? Post Market Performance Follow-up (PMPF) refers to proactive method of collecting and evaluating performance and relevant scientific data generated during the use of device already placed on market and is CE certified to conform to safety, performance and scientific validity. PMPF is a continuous process which updates performance evaluation and is a part of PMS plan.
The aim of PMPF studies
- Ensure Conformity to safety and performance of device throughout the lifetime of device
- To identify new risks or limitations to performance and contraindication
- Identifying and analysing emergent risks on the basis of factual evidence
- Ensure continued acceptability of clinical evidence and benefit- risk ratio
- Identify systematic misuse
PMPF Planning Process
The PMPF (Post-Market Performance Follow-Up) planning process is a systematic approach to gathering and analyzing real-world data about the performance and safety of in-vitro diagnostic (IVD) medical devices after they are placed on the market. It involves setting objectives, identifying data collection methods, and establishing timelines to ensure continuous compliance with regulatory requirements. By proactively monitoring performance, manufacturers can detect potential risks, improve device reliability, and maintain public safety. A robust PMPF plan demonstrates a manufacturer’s commitment to quality and ensures alignment with IVDR standards, enhancing trust among stakeholders and regulatory bodies.
Performance Evidence Matrix
The Performance Evidence Matrix is a systematic framework used to assess and document the ongoing performance of IVD medical devices. It consolidates clinical and analytical data from various sources, including real-world usage and feedback, to ensure the device meets its intended purpose effectively. This matrix supports regulatory compliance by identifying performance trends, risks, and opportunities for improvement. By maintaining a well-structured evidence matrix, manufacturers can demonstrate the safety, reliability, and effectiveness of their devices, fulfilling essential requirements under regulations like IVDR while enhancing patient outcomes and fostering trust in their products.
PMPF Plan Drafting
A Post-Market Performance Follow-up (PMPF) plan is a critical component of the regulatory compliance process for In Vitro Diagnostic (IVD) medical devices. It serves as a proactive mechanism to gather and evaluate real-world data on the performance of devices once they are in the market. An effective PMPF plan ensures ongoing safety and reliability while addressing potential risks that may emerge during the product’s lifecycle.
Drafting a robust PMPF plan involves identifying performance objectives, defining data collection methods, and establishing evaluation criteria. It also includes a timeline for data analysis and mechanisms for reporting findings to regulatory authorities. Key elements such as clinical data review, feedback from end users, and adverse event monitoring are integral to the process.
A well-structured PMPF plan not only complies with regulatory requirements under IVDR but also supports manufacturers in improving their products and maintaining market trust. By leveraging expert guidance, manufacturers can ensure their PMPF plan aligns with international standards, helping them stay ahead in the competitive IVD industry.
PMPF Plan Implementation
PMPF is regulated as Annex III Part B of EU IVDR 2017/746. A manufacturer of In-vitro diagnostic devices is required to prepare a PMPF plan and an assessment report. PMPF is an important element of PMS plan and the main findings of PMPF are included in PMS report or Periodic Safety Update Report.
If PMPF is not deemed appropriate then a justification shall be provided and documented within the performance evaluation report.
Maven Profcon Services LLP. is a leading regulatory consultancy and our team IVD experts can provide support to IVD manufacturers for the following:
- Develop relevant strategy to generate all necessary data,
- Support the development of PMPF processes and plans and
- Helping with the successful implementation of PMPF activities
- Where deemed appropriate, justification for non-applicability of PMPF
