A Q&A document on the EU Regulation’s Unique Device Identification (UDI) system has been published to answer some of the most burning questions when it comes to the application of UDI to medical devices and IVDs. The document covers the following themes:
- UDI-DI.
- Basic UDI-DI (BUDI).
- UDI Labelling.
- UDI Rules for System and Procedure Packs (SPPs) and Configurable Devices.
- Retail Point of Sale, Promotional Packs and Marketing Related Samples.
- Kits
- UDI and Eudamed.
In one of the questions asked regarding ‘How should the Basic UDI-DI be assigned?’, we believe the answer provided could have gone further. The guidance says that assigning the BUDI should be up to the manufacturer and that they should follow any rules for grouping as provided by their Notified Body (if applicable). We recently put together our own guidance on EU UDI and assigning BUDI, and provide the following recommendations for grouping devices:
Level 1: Intended Purpose
Only devices with the same intended purpose shall be listed under a single Basic UDI-DI. This includes a consideration of indications, contra-indications, target users and target patients.
Level 2: Classification
Devices with different classifications shall be separated into a different Basic UDI-DI.
Level 3: Design Characteristics
The design of devices under a single BUDI grouping should have the same essential design characteristics. One example is when a product with the same intended use and classification can be provided active or not active (e.g. hot vs cold endoscopic instruments); these should have two separate BUDIs. Another example may be one in which a variant has a measuring function.
Level 4: Manufacturing Characteristics
Devices with different manufacturing characteristics shall be assigned a different BUDI. In some cases, the same device may be provided as sterile and non-sterile; these should have separate BUDIs.
