‘Level of clinical evidence’: this terminology is used in the MDR with respect to requirements for demonstration of conformity with the relevant GSPR and overall benefit-risk. It is understood to encompass the amount and quality of evidence (i.e. its characterisation by quality, quantity, completeness and statistical validity, etc.) required to demonstrate safety, performance and the benefit-risk conclusion of a medical device. It should not be confused with the term ‘levels of evidence’ (as used in evidence-based medicine) which is used to rank study designs, and is only a part of the concept ‘level of clinical evidence’. Regarding the assessment of the level of clinical evidence for the device in question, see sections 6.3 and 6.5d of this document.
[Definition according to MDCG 2020-6 No. 1.2]