IMDRF launches consultation on clinical evidence for IVD medical devices

11th March 2026

Summary:
The International Medical Device Regulators Forum (IMDRF) has launched a public consultation on a draft document titled Clinical Evidence for In Vitro Diagnostic Medical Devices: Definitions and Principles of Performance Evaluation. The proposed guidance aims to clarify key concepts related to clinical evidence for IVD devices, including definitions and the principles used to assess device performance. It forms part of ongoing international work to update and harmonise regulatory approaches to evaluating the safety and effectiveness of diagnostic technologies. Stakeholders are invited to review the draft document and submit feedback to help refine the guidance before it is finalised. The consultation opened on 4th March 2026 and will close on 5th May 2026.

Link: https://www.imdrf.org/consultations/clinical-evidence-ivd-medical-devices-definitions-and-principles-performance-evaluation

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