Level of clinical evidence

Under the EU MDR, the manufacturer has to justify why the clinical evidence it holds is enough for its particular device, and notified bodies challenge that justification. The question is not only how many patients were studied but whether the data are complete, of good quality and statistically sound. It is a different idea from the 'levels of evidence' hierarchy that ranks study designs.

• ‘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.

MDCG 2020-6, Section 1.2, Additional terms not defined in MDR Article 2