FDAnews Device Daily Bulletin
Medical Devices / Regulatory Affairs

IMDRF Pursues Global Clinical Device Evaluations

April 16, 2019
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The IMDRF’s Medical Device Clinical Evaluation Working Group, led by China, released three consultation documents aimed at integrating regulations across regions to reduce redundant clinical trials for devices.

One document provides background on what’s required for clinical evaluations of medical devices. The second updates definitions of acceptable clinical evidence. The third deals with when a clinical evaluation should be conducted for a device.

The Chinese working group included representatives of devicemakers, regional coordination organizations and industry associations. Medtronic was one of the first companies to join the group.

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