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EN ISO 18113-4:2024 Standard

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  Keywords:

#intended #information #calibrators #ivd #general

  Directive

In vitro diagnostic medical devices Regulation ((EU) 2017/746)

  Last Official Journal reference

Wednesday 28th of January 2026

  Description:

In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 4: In vitro diagnostic reagents for self-testing (ISO 18113-4:2022)

  Purpose

ISO 18113-4 specifies requirements for information supplied by the manufacturer of in vitro diagnostic (IVD) reagents, calibrators, and controls intended for self-testing. It can also be applied to accessories. It is applied to the labels for outer and immediate containers and to the instructions for use. ISO 18113-4 is concerned solely with information supplied with IVD reagents, calibrators, and control materials intended for self-testing. It is intended to be used in conjunction with ISO 18113-1, which contains the general requirements for information supplied by the manufacturer and definitions of general labelling concepts. ISO 18113-4:2022 text has been approved in Europe as EN ISO 18113-4:2024 without any changes.

  Publication

Wednesday 28th of January 2026

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