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
“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.”
Unique Device Identification (UDI) - Healthcare - GS1
According to the International Medical Device Regulators Forum (IMDRF), a Unique Device Identification (UDI) system is intended to provide a single, globally harmonised system for positive identification of medical devices through distribution and use.
Unique Device Identifier - UDI - European Commission - Public …
Jul 30, 2024 · 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) and will also be the access key for device-related information entered in future European medical device database.
UDI-DI, Basic UDI-DI, GTIN, and GMN: What’s the Difference?
Learn how UDI-DI (aligned with GS1 GTIN) uniquely identifies product variations, while Basic UDI-DI (aligned with GS1 GMN) represents device families. Ensure regulatory compliance and streamline product traceability for medical devices under MDR and IVDR.
Basic UDI-DI identification information - Europese Commissie
Fill in the Basic UDI-DI identification details and click on Save & Next: Important 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.
How to understand Basic UDI-DI and UDI - Obelis Group
Sep 18, 2019 · Unlike the US FDA regulation, the EU regulations introduce a new identifier, the “Basic UDI-DI”, a regulatory code to group devices with the same intended purpose, risk class, essential design, and manufacturing characteristics. Basic UDI-DI …
Basic UDI-DI: What it is and How it Works [Definition]
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.
Overview of the EU Basic UDI-DI - Compliance Navigator
Sep 2, 2021 · The Basic UDI-DI is an EU approach for linking devices to their regulatory documentation and it is intended to uniquely identify the product model throughout the entire life cycle of the product. The MDCG’s definition of it is:
UDI Basics | FDA - U.S. Food and Drug Administration
Device identifier (DI), a mandatory, fixed portion of a UDI that identifies the labeler and the specific version or model of a device. Distinct identification code required by §1271.290 (c) for a...