Bureau Veritas at 1Med’s Webinar on PMCF under MDR

This webinar will examine PMCF under MDR as a key driver for generating robust, defensible, and sustainable post‑market clinical evidence throughout the entire medical device lifecycle.

In the context of the European Medical Device Regulation (MDR), Post‑Market Clinical Follow‑Up (PMCF) has evolved into a mandatory, continuous, and strategic process. It is no longer considered a standalone activity, but a central pillar supporting clinical evaluation, risk management, post‑market surveillance (PMS) and, where applicable, the Summary of Safety and Clinical Performance (SSCP).

Despite this, many medical device manufacturers continue to face challenges in translating MDR requirements into effective and sustainable PMCF strategies. Key difficulties include defining proportionate PMCF activities, identifying appropriate real‑world data sources, ensuring methodological rigor and data integrity, and maintaining consistent alignment between PMCF, PMS, and clinical documentation—often under significant budgetary and resource constraints.

Which key topics will be addressed during the webinar on PMCF under MDR?

• Manufacturers’ Perspective
  Key challenges in implementing PMCF under MDR, including proportionate activities, surveys, legacy devices, and real‑world data.
• Notified Body Perspective - Bureau Veritas
  Most common PMCF deficiencies identified during assessments, covering methodology, data governance, and integration into clinical evaluation and risk management.
• Operational and Strategic Perspective - 1MED
  Practical and sustainable approaches to design compliant and defensible PMCF activities, based on risk and proper use of real‑world data.
   

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