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Solutions Circle: What Can Manufacturers Learn From Effective PMS/PMPF Strategies to Strengthen Their Clinical Evidence With The IVDR Transition Deadline Approaching?
Description: Complying with the new EU Requirements for IVD’s has become very challenging for IVD manufacturers and notified bodies, as seen with the transitions applied based on IVD classification over the next few years and the extension and transitions put foward. However, the deadlines are starting to approach for IVDR certification (Class D 2024, Class C 2025 etc) and with manufacturers striving for clinical evidence generation for performance evaluation we start to see Post Market Surveillance requirements begin to slip (which are already in force). As stated in Regulation 2022/112, post-market surveillance, market surveillance, vigilance, registration of economic operators and of devices are enforce as per IVDR. So, leads to manufacturers needing to implement an effective PMS as well as carry out all activities for IVDR QMS compliance and generation of performance evaluation to meet IVDR requirements. Therefore, if manufacturers think carefully the usage of effective PMS/PMPF strategies and plans/Reports, which, if generated correctly, could be used for effective contribution to Clinical evidence to fill gaps especially were intended purpose has changed to meet IVDR requirements and to identify previously not identified risks for their devices.
Learning Objectives:
recap of process of the Performance Evaluation and Post Market Surveillance, per IVDR.
Discussing Post Market Surveillance Data and strategies that could led to strong PMS Report and/or Periodic Safety Report generation
Discussing effective PMPF strategies can lead to more inclusive Clinical Evidence for devices. Providing hands-on information on what the biggest learnings are from these views (including case studies) and how IVD manufacturers can benefit from this, when preparing their own technical documentation for their devices
