IMDRF Closing Two Working Groups, Says Jobs Are Done
The International Medical Device Regulators Forum has finished work on two key programs.
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A new international draft guideline proposes an informal checklist that medical device regulators can use to assess the usability of patient registry data to support regulatory decision-making.
The International Medical Device Regulators Forum says its new terms and codes for reporting adverse events are readily usable and will speed up safety-signal detection.
The US agency was hoping to boost regulatory harmonization with the wholesale adoption of an international guideline on standalone medical device software, but medtech companies are worried that the guideline does not link up with US legislation and requirements.