Essentials of European Medical Device Regulatory Affairs

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

The Organisationfor Professionals inRegulatory Affairs

GSPRs General Safety and Performance Requirements

The Organisationfor Professionals inRegulatory Affairs