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) now includes a standard for Companion Diagnostics. This edition will replace the current edition on 20 April 2026. Until that date, the existing requirements remain in force.
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Publication year
2026
Resource type
Standard