Requirements for the Development and Use of In-house In Vitro Diagnostic Medical Devices (sixth edition, 2026)
This incoming amendment to the Requirements for Development and Use of In-house In Vitro Diagnostic Medical Devices includes new requirements for In House In Vitro Medical Device (IVD) software that includes specific requirements for Artificial Intelligence (AI) and Machine Learning (ML) enabled software. This will replace the fifth edition, 2025 in July 2027. This amendment is not yet in force. To provide feedback on additional resources required for implementation of the IVD software requirements please sign-up for updates or email the team. The Commission will also undertake a complete review of these requirements throughout 2027 and welcomes expressions of interest from interested stakeholders. Please email the team.
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Requirements for the Development and Use of In-house In Vitro Diagnostic Medical Devices (sixth edition, 2026)
- For more information:
- Pathology Standards
- Publication Year:
- 2026
- Resource Type:
- Standard
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