Since 2013, the FDA (Food and Drug Administration) has been defining labeling procedures for medical devices, surgical instruments, implants, etc. In this context, it was decided to apply a UDI (Unique Device Identification) carrier to all medical products and their packaging.
In contrast to Europe, products for medical technology in the USA are approved by the FDA and assigned to risk classes. The CDRH (Center of Devices and Radiological Health) represents a part of the FDA and is responsible for the approval and monitoring of these products.
In Europe, the “European Medical Device Regulation” (MDR) introduced in 2017 regulates approval and classification. The MDR is currently introducing the UDI labeling requirement in Europe as well. The UDI marking obligation includes the marking of products with a unique product identification code (UDI) and the storage of this information in an EU-wide database (Eudamed). Thus, the UDI marking obligation will apply to all products and at all higher packaging levels (except shipping containers) in medical technology – regardless of the risk class – from May 26, 2021.