Introducing My Basic UDI-DI Manager: Simplify EUDAMED Compliance
Do you need to register your Basic UDI-DI following the MDR and IVDR Regulation?
GS1 has the solution to simplify this process.
Don’t get overwhelmed by the European Commission's legislation for publishing medical device information for the Medical Device Regulation (MDR) and In-Vitro Diagnostics Regulation (IVDR). GS1 Belgium & Luxembourg simplifies this process with My Basic UDI-DI Manager, your comprehensive solution for storing and publishing data in a structured and verified manner.
Effortless UDI-DI Registration and Efficient Bulk Management
Starting your UDI-DI registration is simple in My Product Manager, where you easily manage product specifications, laying the groundwork for EUDAMED registration. And with just a few clicks, My Product Manager allows you to create the UDI-DIs for all the products in a range in bulk, just by modifying what’s needed in an Excel sheet. With My Basic UDI-DI Manager you will consecutively create and edit Basic UDI-DIs effortlessly, and finally publishing your data to EUDAMED.
Do you know that this platform makes your data accessible to hospitals and purchasing centres, both nationally and internationally?
Robust Quality Checks
To ensure data accuracy, GS1 Belgium & Luxembourg has integrated several checks into the system. This helps to avoid inconsistencies and errors before final publication. With GS1's commitment to quality data, you can meet your legal obligations quickly and correctly.
Jan Van der Putten, Quality and Process Engineer of Handi-Move:
Despite the complex nature where regulations, ICT platforms, and global sector agreements converge, GS1 Belgilux provided us with individual guidance. In the past, we had many one-on-one conversations where a healthcare specialist took ample time to answer our questions. This helped us gain the proper insights into the legal requirements."
Olivier Ménage, CEO of Mona.Health:
"As a manufacturer of medical devices, we are subject to various regulations. Using My Basic UDI-DI Manager has simplified our working processes while ensuring we remain fully compliant with MDR legislation. The platform allows us to link data entered in advance into My Product Manager Share, and after validation, publish it on EUDAMED. Creating the Basic-UDI takes just five minutes, making it a practical solution for our needs."
Key Benefits of My Basic UDI-DI Manager:
- Compliance: Create Basic UDI-DIs according to medical device regulations.
- Validation Rules: Maintain data integrity with built-in checks.
- Bulk Actions: Manage large datasets efficiently.
- Time-Saving: Streamline your data management processes.
- Centralised Hub: One platform for all your data needs.
- Personal guidance: Dedicated healthcare support team.
