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Requirements for the Development and Use of In-House In Vitro Diagnostic Medical Devices (Fifth Edition)

Notice of Commencement: The amended Requirements for the In-House In Vitro Diagnostic Medical Devices (Fifth Edition, 2025) is now in force and includes a standard for Companion Diagnostics. This edition superseded the Fourth Edition, 2018 on the 20 April 2026.

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Requirements for the Development and Use of In-House In Vitro Diagnostic Medical Devices (Fifth Edition)

Requirements for the Development and Use of In-House In Vitro Diagnostic Medical Devices (Fifth Edition)
Publication Year:
2026
Resource Type:
Standard

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