Clinical evidence

The words sufficient amount and quality carry the weight here. How much evidence is enough depends on the device's risk, novelty and claims, and the manufacturer has to justify the level it relies on.

‘clinical evidence’ means clinical data and clinical evaluation results pertaining to a device of a sufficient amount and quality to allow a qualified assessment of whether the device is safe and achieves the intended clinical benefit(s), when used as intended by the manufacturer;

EU MDR, Article 2(51)

‘clinical evidence’ means clinical data and performance evaluation results, pertaining to a device of a sufficient amount and quality to allow a qualified assessment of whether the device is safe and achieves the intended clinical benefit(s), when used as intended by the manufacturer;

IVDR, Article 2(36)

The MDR refers to clinical evaluation results, while the IVDR refers to performance evaluation results, in line with the different evaluation processes in each regulation.