Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR)
For manufacturers
Medical device manufacturers must label all classes of medical devices with a UDI since 26 May 2021. All classes of IVDs will follow in 2023. This European legislation aims to increase transparency and improve traceability.
What to do?
Identifying articles
Order a GS1 code pack to identify and code articles. In the healthcare sector, the GTIN must not contain 13 digits, but 14. Therefore, add a leading zero.
Unique Device Identification (UDI)
With the unique article code, create a UDI for each version or model of medical device and IVD. Place the UDI in text form and as a symbol on the product. Use a GS1 DataMatrix or GS1-128 barcode for this.
Global Model Number for Basic UDI-DI
Create a Global Model Number to implement the Basic UDI-DI, this is for identifying product models and/or product families. The Basic UDI-DI must be included in relevant certificates, such as the CE certificate and technical documentation. This number does not appear on the packaging.
Europese database EUDAMED
EUDAMED is the European Database on Medical Devices. This database contains information on medical devices and manufacturers.
Optional GS1 standards
- Global Location Number (GLN): to uniquely and unambiguously identify locations.
- GS1 Data Source: to share product data with hospitals, clinics and databases globally in a standardised way, from a single source.