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Category
Supplementary Resource
Standard
HL7_DAM_UDI _R1_INFORM_2021OCT
Version
Release 1
Access
Open
Status
Active
Created
October 2021
The Unique Device Identifier (UDI) Domain Analysis Model (DAM) describes the business, interoperability and data requirements associated with a formal identification scheme for medical devices throughout distribution and use.

The DAM aims to enable semantic interoperability across stakeholders (e.g. manufacturers, healthcare providers, researchers, inventory management, patient safety, public safety, payers) who need to share information about medical devices that are subject to unique identification systems mandated in their jurisdictions.

This document contains the requirements for reporting and using UDIs for the identification of implantable medical devices. Implantable devices are subject to UDI labelling regulations, and because implantables pose a heightened safety risk, reporting of the UDI information for implantable devices is a priority.

Main sections:

• Background of UDI

• Regulatory requirements for UDI

• UDIs for medical devices

• Domain overview

• Use case overview

• Detailed use cases

• Domain analysis
Access HL7 Domain Analysis Model: Unique Device Identification (UDI), Release 1

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