Consultation closed

Unique Device Identification system (UDI System)

Start date
Closing date
Working group
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 [at] ec.europa.eu (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

Member sites

Regional harmonization initiatives

APEC LSIF Regulatory Harmonization Steering Committee

Global Harmonization Working Party (GHWP)

Pan American Health Organization (PAHO)

African Medical Devices Forum (AMDF)

Official observers

Argentina, National Administration of Drugs, Food and Medical Devices

World Health Organization (WHO)

Swissmedic

 

Affiliate members

 

Chile - Public Health Institute of Chile (ISP)

Chinese Taipei Taiwan Food and Drug Administration (TFDA)

Cuba - Centro para el Control Estatal de Medicamentos, Equipos y Dispositivos Médicos (CECMED)

Egypt - Egyptian Drug Authority  (EDA)

Israel - The Medical Technology, Health Information, Innovation and Research Directorate (MTIIR)

Montenegro - Institute for Medicine and Medical Devices of Montenegro (CINMED)

Nigeria - National Agency for Food and Drug Administration Control (NAFDAC)

South Africa - South African Health Products Regulatory Authority (SAHPRA)