Unique Device Identification Procedure

$149.00
$149.00
Unavailable
per item
The Unique Device Identification (UDI) Procedure governs the process of creating, submitting and maintaining Unique Device Identification (UDI) and BASIC UDI-DI codes for the FDA GUDID and EUDAMED database systems. The UDI procedure meets FDA / EUDAMED Issuing Agency GS1 standards and the requirements of 21 CFR Part 830 and MDR 2017/745.
  • ISO 13485:2016 Compliant
  • FDA QSR Compliant
  • ​MDR 2017/745 Compliant
  • MS Word Format
  • ​Digital Content - Instant Download
SKU: SOP 7-037

Unique Device Identification (UDI) Procedure

The Unique Device Identification (UDI) Procedure governs the process of creating, submitting and maintaining Unique Device Identification (UDI) and BASIC UDI-DI codes for the FDA GUDID and EUDAMED database systems. The UDI procedure meets FDA / EUDAMED Issuing Agency GS1 standards and the requirements of 21 CFR Part 830 and MDR 2017/745.

Unique Device Identification (UDI) Procedure Overview

​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 GUIDID system data entry.

Unique Device Identification (UDI) Procedure Compliance

The Unique Device Identification (UDI) Procedure is ISO 13485:2016, MDR 2017/745 and FDA 21 CFR Part 820 Compliant.
​For more information about our Unique Device Identification (UDI) Procedure contact us at [email protected] 

RELATED LINKS

​Design Control Procedure
​Medical Device Labeling Procedure Bundle
​CE Marking Procedure
​Label Review and Approval Procedure
Unique Device Identification Procedure
Unique Device Identification Procedure

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