Identifying medical devices is not easy. Here you will find all the answers to your questions.
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UDI stands for Unique Device Identification. It is an identification system for medical devices (UDI) designed to give them a positive, unique and globally harmonised identification each time. This system requires that the label on medical devices contain this unique identification when the products are distributed and used, that it is transferable using automatic identification and data collection, and that its meaning is human readable if necessary. The UDI-DI (device identification code) is also linked to a public UDI database, specific to jurisdiction.
A UDI consists of a combination of a Device Identifier as unique identifier (GS1 product code/GTINs) and one or more Production Identifiers (Application Identifiers (AIs)).
- Article code/GTIN: AI (01)
- Best before date: AI (17)
- Production date: AI (11)
- Batch/lot number: AI (10)
- Serial number: AI (21)
In healthcare, medical device manufacturers generally use the Application Identifiers (01) GTIN, (17) Expiry Date, (11) Production Date, (10) Batch or Lot Number and (21) Serial Number. The AIs let systems know what information follows (e.g. AI (01) indicates that the GTIN follows and AI (17) that an expiry date follows). The manufacturer incorporates the AIs into the symbol and as human readable form (HRI) text.
The US Food and Drug Administration (FDA), the European Commission and other regulatory bodies put patient safety at the centre of the development of UDI regulations for medical devices and in-vitro diagnostics (IVDs) and strive for a globally harmonised and consistent approach, aligned with the guidelines of the International Medical Device Regulators Forum (IMDRF).
GS1 awards UDIs as an agency/entity and is recognised by several authorities worldwide, including the United States, the European Union, China, South Korea and Saudi Arabia. This means that manufacturers supplying regulated medical devices to these markets use GS1 standards to implement UDI requirements.
The GS1 standards system provides a global framework for identifying, capturing and sharing information of healthcare products, enabling consistent UDI implementation worldwide.
You can create your UDI-DI automatically using My Product Manager.
A UDI must be placed on the product label (on the packaging and sometimes on the medical device itself). A UDI is also placed on all higher packaging levels. In human readable form: Human Readable Interpretation (HRI). In symbol form: in the form of a barcode (Automatic Identification and Data Collection - AIDC)
The Basic UDI-DI is required to identify a medical device as a product family. Basic UDI-DI is a term used by the European Commission. Global Model Number (GMN) is the standard that GS1 has developed for this purpose.
For the Basic UDI-DI, GS1 has developed the standard Global Model Number (GMN). The manufacturer of the medical device is responsible for creating the Basic UDI-DI. You can calculate this number with the calculation tool. To do this, you need a company number from a GS1 code package. Take the company number from your code package, add an internal model reference to it and the calculation tool will then calculate 2 control characters across the board. For the internal model reference, you can use any digits and letters from Figure 7.11-1 in the GS1 General Specifications. In total, the GMN may not contain more than 25 characters (23 + 2 control characters).
No, you do not need to register the Basic UDI-DI or submit it to GS1.
Since 26 May 2021 under the MDR and from 26 May 2022 under the IVDR.
No, the Global Model Number for the Basic UDI-DI will not appear on the medical device packaging.
The UDI is the unique product identification and is different for each product with, for example, a different content, language, shape or colour. Using the GS1 GTIN Allocation Rules, you can determine how many product codes you need. A Basic UDI-DI identifies a group of products, in which each product in the group has its own UDI. The UDI must be printed on the product in barcode format; the Basic UDI-DI is not printed on the product packaging.
The internal model reference is compiled by the manufacturer. Numbers, letters and characters can be used. For an overview of the characters that can be used for the internal model reference, see Figure 7.11-1 in the GS1 General Specifications.
No, the costs are for the code package. From this comes a company number with which the Global Model Number (GMN) can be created.