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IMDRF consults on adverse event reporting

  • Posted by: inetika
  • Category: GLOBAL NEWS

The international Medical Device Regulators Forum (IMDRF) has published a consultation document on terminologies for categorized adverse event reporting. The consultation which runs until 10 September 2019 covers terminology, codes and coding structure. A number of annexes deal with cause investigation, health effects and terms and codes for parts and components. However, as yet there is not text for the annexes.

A globally harmonised system of codes and terminology will benefit manufacturers reporting to multiple jurisdictions by reducing the burden of managing multiple coding systems when preparing medical device adverse event reports. For regulators it supports analysis of safety, quality and performance information in a manner that can readily be shared with other authorities. In the case of patients there will be a faster local and international response to medical device adverse events including those related to medical device malfunctions or deteriorations. Finally, healthcare providers will benefit from the use of common terms with manufacturers and regulators enhancing accuracy, reliability and utility of the reports, especially when larger datasets need to be pooled and analysed.

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