4/2/2013

The national competent authorities report program is being used by international stakeholders to communicate corrective actions for medical devices found to be at risk, but not to exchange information on serious adverse events or risk assessments on which corrective actions are based, a survey conducted by the International Medical Device Regulators Forum found. The survey also found that information is sometimes exchanged too late, and some participants do not contribute information at all. The stakeholders surveyed suggested ways to improve the system, such as including data from registries as well as unfavorable findings from pre-market evaluations.

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