Consultation closed

Unique Device Identification system (UDI System)

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Unique Device Identification (UDI) Application Guide

A Proposed guidance Document has been released by the International Medical Device Regulators Forum (IMDRF) UDI Working Group, as well as two Information documents on UDI.

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

Consultation documents

N48 - Unique Device Identification system (UDI system) Application Guide
N53 - Use of UDI Data Elements across different IMDRF Jurisdictions
N53 - Annex - Use of UDI Data Elements across different IMDRF Jurisdictions
N54 - Recording Unique Device Identifiers in Electronic Health Sources

Please use the comments templates to provide comments on the Proposed Documents and email comments to Salvatore Scalzo.

Comments - N48 - IMDRF UDI Application Guide
Comments - N53 - Use of UDI Data Elements across different IMDRF Jurisdictions
Comments - N54 - Recording Unique Device Identifiers in Electronic Health Sources