Left-over sample

Performance studies that use only left-over samples are exempt from some IVDR study requirements, subject to national rules on consent and ethics review. They are a common, practical source of clinical performance data.

Unadulterated remainder of human derived samples collected as part of routine clinical practice and after all standard analysis has been performed. Such specimens/samples would be otherwise discarded as there is no remaining clinical need for them. This can include specimens collected for research or other purposes not connected to the clinical performance study in question. Left-over samples include “specimen or sample that are collected in the past and obtained from repositories (e.g. tissue banks, commercial vendor collections). See ISO 20916 section 3.25.

MDCG 2024-4, Section 4.11