Unique Device Identification Procedure

Plan medical device UDI assignment, labeling and database records with this editable Unique Device Identification (UDI) Procedure. It covers FDA device identifiers and GUDID data entry, EU Basic UDI-DI and EUDAMED device registration, issuing-agency selection, packaging levels and change control.

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Supplied as one editable Microsoft Word document in a digital download.

FDA and EU device identifiers and database records

The Unique Device Identification (UDI) Procedure is applicable to "Labelers" of all medical devices and applicable third party packagers labeling product on behalf of the manufacturer. The Unique Device Identification Procedure provides detailed instruction on UDI implementation planning, barcode format planning, Issuing Agency selection, and step by step FDA GUDID system data entry.

The UDI instructions distinguish the device identifier from production information and address assignment at the appropriate device and packaging levels. They describe coordination with an issuing agency, controlled label content and submission of the required device data to the relevant database. The procedure also covers updates when a change affects identification, allowing regulatory, labeling and document-control teams to maintain consistent records.

The revised procedure references U.S. UDI requirements in 21 CFR Part 830 and EU MDR Regulation (EU) 2017/745.

For the review and approval of the corresponding labels and IFU, see the Label Review and Approval Procedure.

For EU CE marking and its broader technical-documentation workflow, see the CE Marking Procedure. Both procedures are included in the Medical Device Labeling Procedure Bundle.

Using an eQMS? These editable Microsoft Office files can be imported into any electronic quality management system (eQMS) that manages Word and Excel documents, or used in a paper-based system. Adapt the approval, signature and record steps to your system’s workflow, and validate the eQMS software under your own QMS. See how to use A.P. Lyon procedures in an eQMS.

Practical guide

Read Medical Device Labeling, UDI and CE Marking: Keep Claims Aligned for workflow guidance, a checklist and common mistakes.

Part of a procedure bundle

This document is also included in Medical Device Labeling Procedure Bundle. Explore the bundle for the related documents.