General Safety and Performance Requirements under the Medical Devices

Medical device manufacturers are obliged to demonstrate that their devices meet the General Safety and Performance Requirements (GSPRs) established in Annex I of the MDR. In the past, under the MDD, an Essential Requirements “checklist” was frequently used to show conformity. However, the MDR now requires specific information to be included to verify, validate and justify that GSPRs are met and a similar checklist document may no longer be adequate. In this presentation, we will explore these new requirements and provide insights into how to provide more robust justifications, with and without the benefit of presumption of conformity conferred by common specifications and/or technical standards harmonised with the MDR. In addition, we will look at some common issues related to GSPRs and lessons learned when submitting technical documentation for review. Early engagement with GSPRs to integrate them into design requirements and device specifications is key to ensure that adequate evidence is generated throughout the device development life-cycle to provide the basis for justification. Finally, meeting the GSPRs is an ongoing exercise to be ensured each time that devices are placed on the market. The Regulatory Compliance Strategy applied by the manufacturer therefore needs to include how applicable GSPRs are identified and met on an ongoing basis, in particular in the event of design changes, emerging risks or changes to the related standards.