The Basic UDI-DI is the main key in the database and relevant documentation (e.g. certificates, declaration of conformity, technical documentation and summary of safety and clinical performance) to connect devices with same intended purpose, risk class and essential design and manufacturing characteristics.
Unique Device Identification (UDI) - Healthcare | GS1
The EU Regulations have introduced a new concept: the Basic UDI-DI, that aims at grouping regulated medical devices under the same identifier. GS1 has developed a new key to support the implementation of the Basic UDI-DI: the Global Model Number (GMN).
UDI Basics | FDA - U.S. Food and Drug Administration
A unique device identifier (UDI) is a unique numeric or alphanumeric code that generally consists of the following: Device identifier (DI), a mandatory, fixed portion of a UDI that...
Overview of the EU Basic UDI-DI - Compliance Navigator
Sep 2, 2021 · The new EU MDR 2017/745 and IVDR 2017/746 regulations require the assignment of a Basic UDI-DI to medical devices. The concept of a Basic UDI-DI is new and currently unique to the EU. The purpose and use of the Basic UDI-DI is different from the use of the device UDI-DI.
Basic UDI-DI: What is it and How to Assign it for Your Medical …
Oct 14, 2022 · Basic UDI-DI (or BUDI-DI for short) is an entirely new method of device identification, one which groups together devices with multiple UDI-DIs. With Basic UDI-DI, the BUDI-DI number links devices with the same intended purpose, risk class, and essential design and manufacturing characteristics.
Unique Device Identifier - UDI - European Commission - Public …
Jul 30, 2024 · The unique device identification (UDI) is a unique numeric or alphanumeric code related to a medical device. It allows for a clear and unambiguous identification of specific devices on the market and facilitates their traceability. The UDI comprises the following components.
“The Basic UDI-DI is the primary identifier of a device model. It is the DI assigned at the level of the device unit of use. It is the main key for records in the UDI database and is referenced in relevant certificates and EU declarations of conformity.”
Basic UDI-DI identification information - Europese Commissie
EUDAMED will validate the Basic UDI-DI code based on the specific format for each Issuing Entity and will prevent you from going further if the code is not valid.
Unique Device Identification System (UDI System) | FDA
Include a unique device identifier (UDI), issued under an FDA-accredited issuing agency's UDI system, on device labels, device packages, and in some instances, directly on the device.
2. What is the Basic UDI-DI? The Basic UDI-DI is the main access key for device-related information in the Eudamed database and it is referenced in relevant documentation [e.g. certificates (including certificate of free sale), EU declaration of conformity, technical documentation and summary of safety and (clinical) performance)].