In the field of digital health, Medical Device Software (MDSW) apps are increasingly popular, used by patients and healthcare professionals to [...]
Instructions for Use (IFU) are a key component of medical device labelling in the European Union, essential for product safety and [...]
Unique Device Identification (UDI) is a global identification system designed to enhance the traceability and security of Medical Devices and [...]
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 [...]
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