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Lot or Batch definition for IVDs


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US Regulation (21 CFR Part 820 (m))
Lot or batch means one or more components or finished devices that consist of a single type, model, class, size, composition, or software version that is manufactured under essentially the same conditions and that are intended to have uniform characteristics and quality within specified limits.

EU Regulation

MEDDEV 2.5/6 Rev.1 February 1998
"Homogeneity of production batches“
Certain statistical verification procedures are only meaningful when batches, (lots), are
A batch is considered homogeneous when equivalent parts or materials are manufactured and/or tested in the same manner, without interruption, typically on the same day or in the same time period, and produced by the same person, or with the same machine/equipment set-up and fulfill the same specifications.
For IVD's and certain other medical devices, such as dental material the following complementary definition shall apply: Mixtures of substances such as reagents aliquoted from the same bulk mixture are considered homogeneous if the mixing and aliquoted processes are validated.

Note: In ISO 2859, „lot“ is defined similar to "homogeneous batch“ of this paper.

”batch (lot): 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.”
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