Clinical evaluation

Clinical evaluation is not a single report written for certification. It continues through the device's life and is updated with PMCF and post-market data, and the clinical evaluation report shows its current state.

‘clinical evaluation’ means a systematic and planned process to continuously generate, collect, analyse and assess the clinical data pertaining to a device in order to verify the safety and performance, including clinical benefits, of the device when used as intended by the manufacturer;

EU MDR, Article 2(44)

assessment and analysis of clinical data pertaining to a medical device to verify the clinical safety and performance of the device when used as intended by the manufacturer [SOURCE: GHTF/SG5/N4:2010, Clause 4]

ISO 13485:2016, clause 3.3