Essentials of European Medical Device Regulatory Affairs - October 2019

GSPRs General Safety and Performance Requirements

Article 5 “A device shall meet the general safety and performance requirements set out in Annex I which apply to it, taking into account its intended purpose.” • Similar to the current Essential Requirements • Increase in number from 13 to 23 • Stronger emphasis on risk management and life-cycle • Active devices and software • Labelling requirements significantly expanded

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GSPRs General Safety and Performance Requirements

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