Growing need of Clinical Data, PMCF & Registries for Devices

Post Market Clinical Follow-up (PMCF) studies are a critical component of the clinical evidence required to comply with the new European regulations. As Clinical Evidence Reports (CERs) encounter more and more scrutiny by Notified Bodies (NBs), the gaps surrounding past PMCF work are becoming more evident. "Passive" collection of adverse events, complaints and the like may not be sufficient any longer to demonstrate conformity to the Essential Requirements and to the future Medical Device Regulation (MDR).

Objectives:

  • Clearly define PMCF, Registry needs for Devices
  • Apply CER gaps in safety and performance clinical data to PMCF & registry designs
  • Differentiate adequate PMCF plans from less than adequate PMCF plans
  • Alternate methods of getting Clinical data for your Devices

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