Each batch must have a record of the quantity made and approved for distribution, verified and approved, showing manufacture to the device file and that release requirements were met and documented. Brazil: the device history record must include or reference the manufacture date, components, quantity made, inspection and test results, special process parameters, quantity released, labelling, serial or batch identification and final release (RDC 665/2022 Art 40), and labelling stays unreleased for storage or use until a designated person has checked it, with dated signature in the record (Art 87). United States: labelling must be checked for accuracy by a designated person (UDI or UPC, expiry, control number, storage and handling instructions) before it goes into storage or use, stored to prevent mix-ups, handled in controlled labelling and packaging operations, and the labels and control numbers used for each unit, lot or batch recorded (21 CFR 820.45). Clauses: ISO 13485:2016 4.2.1, 7.5.1, 7.5.8, 7.5.9.1, 8.2.6; RDC 665/2022 Arts 39, 113, 114; MO169 Arts 6, 40, 47, 48, 58, 59.
The graph holds this control, the 0 it maps to, and the evidence behind each claim, over MCP and REST.