Left-over samples

MDCG 2025-5 gives the same meaning as other guidance, adding specimens from research or other purposes not connected to the study. The samples must be unadulterated and no longer clinically needed.

This term should be understood as unadulterated remnants of human derived specimens collected as part of routine clinical practice, for research purposes or other purposes not connected to the clinical performance study in question and after all standard or intended analyses have been performed. Such specimens/samples would be otherwise discarded as there is no remaining clinical need for the individual from which it was collected.

MDCG 2025-5, Question 30