Module 16 2024

17/10/2024

Reasons for allocating a new GTIN

There are a number of requirements for raising a new UDI-DI (GTIN) based upon the requirements from:

1. GS1 (Or chosen Industry Standards Organisation) - GS1 Healthcare GTIN Allocation Rules 2. IMDRF UDI System Application Guide (21 March 2019) 3. US FDA Final UDI Ruling 4. EU MDR (EU) 2017/745 (including EUDAMED Triggers)

At a minimum, a new UDI-DI is required whenever there is a change that could lead to misidentification of the medical device and/or ambiguity in its traceability.

GS1 GTIN Assignment in Healthcare – considerations for raising a new GTIN.

• Product Contained in Package: Is a Stakeholder (e.g. care providers, consumers, patients, regulatory authority and/or trading partner) expected to distinguish the changed or new product from the previous/current product? • Label/Package: Is there a regulatory or liability to disclose a change to the consumer and/or trading partner? • Label/Package: Is there a substantial change impacting the supply chain (e.g. how the trade item is shipped, stored, received, or handled in the clinical setting)?

The Organisation for Professionals in Regulatory Affairs

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Reasons for allocating a new GTIN

Listed in this document are all of the reasons listed that would trigger a new UDI. This list has been consolidated to include triggers from all of the reference documents listed above.

1. A new Basic UDI-DI has been issued (new Risk Class/Intended Purpose/Essential design or manufacturing characteristics) 2. Brand Name 3. Device version or model (updates that would make the product look or behave differently to the end user or require re-registration) 4. Clinical Size (including Volume, Length, Gauge, Diameter) 5. Labelled as single use 6. Packaged sterile 7. Need for sterilization before use 8. Quantity of devices provided in a package 9. Critical warnings or contraindications: e.g. containing latex or Bis (2-ethylhexyl) phthalate (DEHP) 10. New packaging configurations 11. Declared formulation or functionality (fit form or function) 12. Declared net content 13. Dimensional or gross weight change of 20% or more 14. Add or remove certification mark 15. Pre-defined assortment (eg Procedure pack a change to one or more components (including the supplier)) 16. New language version (not required for additional languages) 17. Major changes to software that require a new Version number ie moving to version 3.0 from 2.2 (such as new or modified algorithms, database structures, architecture, new user interfaces or new channels of interoperability). 18. UDI-DI Issuing Agency 19. New Catalogue or model number 20. Addition or removal of Direct Marking 21. Type of PI (Production Information) included in the UDI barcode

The Organisation for Professionals in Regulatory Affairs

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