IMDRF released 3 documents on clinical evaluations, clinical investigations and clinical evidence for medical devices

International Medical Device Regulators Forum (IMDRF) released 3 final documents on clinical evaluations, clinical investigations and clinical evidence for medical devices.

This would replace earlier versions of the documents developed by the Global Harmonization Task Force (GHTF). The documents provides an overview of:

  • General principles of clinical evaluation for medical devices.
  • Principles for designing a clinical investigation and ethical considerations.
  • Key concepts and definitions for clinical evidence.

More details on the IMDRF website:
www.imdrf.org/docs/imdrf/final/technical/imdrf-tech-191010-mdce-n56.pdf
www.imdrf.org/docs/imdrf/final/technical/imdrf-tech-191010-mdce-n57.pdf