UDI in Medical Devices

The Basic UDI-DI is a higher-level identifier than the UDI. It groups together several devices that share the same intended use, [...]

The UDI is required for most Medical Devices and in vitro diagnostic Medical Devices (IVDs) sold in the European Union, except [...]

The timing of UDI implementation varies depending on the risk class of the device, as set out in the MDR [...]

Often, 'UDI medium' is commonly abbreviated to 'UDI code' for the sake of simplicity, especially when referring to the code itself [...]

The UDI code must be applied in specific places to ensure maximum accessibility and readability: On all levels of packaging: [...]

The UDI code must be registered in the European database EUDAMED (European Database on Medical Devices), namely in the UDI/DEV module, [...]

According to MDR (EU) 2017/745 and IVDR (EU) 2017/746, the manufacturer is the entity responsible for the entire UDI management process [...]

No, legacy devices - i.e.devices complying with the old European Directives (MDD 93/42/EEC and AIMDD 90/385/EEC) - are not subject to [...]

The MDR sets out some special rules on UDI for certain categories of devices: Custom-made devices: No UDI code is required [...]