Performance evaluation

Performance evaluation is the IVDR counterpart of clinical evaluation under the MDR. It is a continuous process: the performance evaluation report is updated with post-market performance follow-up data for the whole life of the device.

‘performance evaluation’ means an assessment and analysis of data to establish or verify the scientific validity, the analytical and, where applicable, the clinical performance of a device;

IVDR, Article 2(44)

assessment and analysis of data to establish or verify the ability of an in vitro diagnostic medical device to achieve its intended use

ISO 13485:2016, clause 3.13