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Principles of In Vitro Diagnostic (IVD) Medical Devices Classification

A Proposed Document by the International Medical Device Regulators Forum (IMDRF) in vitro diagnostics Working Group is provided below for public comment.

This consultation closes on Saturday, 25 July 2020.

Working Group Chair: Tatyana Buryakina, Roszdravnadzor, Russia

Thank you for your contribution aiming at the validation of the IMDRF document.

Consultation documents

Please use the comments template to provide comments on the Proposed Document and send comments via email: with the subject line 'IMDRF Consultation'.