Entusia chooses simplicity and ease of use thanks to My Basic UDI-DI Manager
Entusia is an innovative company that offers reusable and sustainable incontinence products for men and women in the healthcare sector. By focusing on both comfort and sustainability, they respond to a growing demand in healthcare. Hans Versmissen, founder and director of Entusia, explains how My Basic UDI-DI Manager helped them to comply with the Medical Device Regulation (MDR).
As a manufacturer of medical devices, Entusia must comply with the European MDR regulation. Their products fall under medical class I (non-sterile). This regulation requires products to be correctly registered and provided with the right identification. An important part of this obligation is registration in EUDAMED, the European database for medical devices.
Simplicity thanks to My Basic UDI-DI Manager
To make this process run smoothly, Entusia chose the GS1 solution My Basic UDI-DI Manager. With this tool, you register your products in a structured way and add the required data thanks to the built-in validation rules.
For Entusia, this made a big difference. The registration process was clear and structured. All relevant products were entered quickly and correctly into EUDAMED, without unnecessary delay.
What stood out most is how strongly GS1 simplifies the process. “The tool guides you step by step and ensures that you enter the required data consistently,” says Hans. This helps you avoid errors and save time.
A quick solution when questions arise
“During the process, questions came up from time to time, which is normal with new regulation,” Hans explains. Thanks to responsive support and communication, these were resolved quickly. “This gave us confidence and allowed us to continue working efficiently,” says Hans.
The combination of a user-friendly GS1 solution and good guidance ensured that the entire journey remained manageable.
Recommended for the sector
Today, Hans looks back positively on the journey. The current process works well and provides a clear structure for companies that need to comply with MDR regulation.
For other companies in the sector, the message is clear: you can significantly simplify this process by working with My Basic UDI-DI Manager. “Especially with deadlines approaching, it is important to start on time and choose an approach that works,” Hans adds.
