Batch

Batch definitions matter for traceability, release testing and recalls. MDCG 2022-3 uses it for the batch verification of class D IVDs by notified bodies.

A defined amount of material, either starting material, intermediate or finished product which is uniform in its properties and has been produced in one process or series of processes.

MDCG 2022-3 Rev.1, Section 3, Definitions (3.2; source: EN 13975:2003)