EUROLAB, with its state-of-the-art accredited laboratories and expert team, offers precise and rapid testing services within the scope of EN ISO 18113-4 testing. EN ISO 18113-4 specifies requirements for information provided by the manufacturer of in vitro diagnostic (IVD) reagents for self-testing. EN ISO 18113-4 also applies to information supplied by the manufacturer with calibrators and control materials intended for use with IVD medical devices for self-testing purposes.
Manufacturers of in vitro diagnostic (IVD) reagents for self-testing provide users with information that will ensure the safe use and expected performance of their devices. The type and level of detail varies depending on intended use and country-specific regulations.
The International Medical Devices Regulatory Forum (IMDRF) promotes the convergence of the development of regulatory systems for medical devices at a global level. Eliminating regulatory differences between jurisdictions could allow patients to access new technologies and treatments sooner. This document provides a basis for harmonizing labeling requirements for IVD reagents for self-testing.
This standard relates to information provided on IVD reagents, calibrators and control materials for self-testing purposes only. It is intended for use in conjunction with EN ISO 18113-1, which contains general requirements for information provided by the manufacturer and definitions of general labeling concepts.
It should be noted that if an IVD reagent is subject to unique identification rules by the regulatory authority, the external label must provide the UDI containing the UDI bearer (Automatic Identification Data Carrier 'AIDC' format) and the Human Readable Interpretation (HRI).
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