Real-world performance

For medical device software, MDCG 2020-1 treats real-world performance data as an input to ongoing clinical evaluation once the device is on the market. It shows whether performance holds up across the full range of users, settings and patients.

Information on real-world device use and performance from a wider patient population than a controlled study.

MDCG 2020-1, Section 3.3, Definitions (definition derived from IMDRF/SaMD WG/N41FINAL:2017)