Consultations
How it works
Draft
Draft
Comments on the proposed document are evaluated and a revised draft document is published.
Final
Final
Once approved by the MC, the final document is published. This is then available for implementation in the respective jurisdictions.
Current consultations
Clinical Evidence for IVD Medical Devices – Definitions and Principles of Performance Evaluation
A Proposed Document by the International Medical Device Regulators Forum (IMDRF) Clinical Evidence for In Vitro Diagnostic Medical Devices Working Group is provided below for public comment.
Started
Closing