FDAnews Device Daily Bulletin
Medical Devices / Regulatory Affairs

IMDRF Clarifies When Competent Authorities Can Share Confidential Information

Nov. 3, 2017
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The International Medical Device Regulators Forum released final guidance that lays out procedures for sharing confidential postmarket surveillance for medical devices among regulators.

The guidance covers criteria to be used for deciding when to exchange information, procedures to follow, requirements for IMDRF members participating in the National Competent Authority Reporting (NCAR) exchange program, and what forms to use for exchanging information.

It also covers sharing information when there is a serious health threat associated with a medical device, and it defines a serious injury as a life-threatening illness or injury; a permanent impairment of a body function or permanent damage to body structure; or a condition necessitating medical or surgical intervention to prevent permanent impairment of body function.

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