Module 16 2024

17/10/2024

Allocation of UDI-DI (GTINs) / Hierarchy • UDI-DIs are allocated to each product at each packaging level. • New UDI-DIs should be allocated whenever a significant change takes place to a product • 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.

Unit of use

Market Unit/Shelf Box

Inner

Shipper

Pallet

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UDI – Hierarchy – Procedure Packs

Unique Device Identifier (UDI) comprises of two parts: A Device Identifier (UDI-DI) – this is a fixed unique number which identifies the manufacturer and product A Production Identifier (UDI-PI) – eg, expiry date & batch number which would identify the specific production batch of product

2 Products packaged into a kit/system which then becomes a product in its own right. • This bag has its own UDI. • The DI would be issued by the manufacturer of this specific product. • The PI for this product would be the batch number allocated by the manufacturer and the expiry date of the shortest shelf life of the products contained within the bag. • The UDI information of each component within the bag should be recorded in the ERP system of the manufacturer against The Batch number for these products

3 10 kits put into a box • This box has its own UDI

1 Assortment of products All have own UDI

• The DI would be unique to this specific packaging level of this specific product and would be issued by the manufacturer of this specific product. • The PI would be the same as is on the bags.

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