Handi-Move relies on My Basic UDI-DI Manager for publication to EUDAMED
Handi-Move has been a member of GS1 for several years for the identification and management of their products. They use My Product Manager to publish their product data in compliance with the FDA regulations in the United States. Thanks to the existing information in My Product Manager, Handi-Move was able to smoothly register with EUDAMED through My Basic UDI-DI Manager, the new application developed by GS1 Belgilux. Jan Van der Putten shares his experience of the process.
About Handi-Move
Handi-Move is a Belgian company that has been active for 40 years in lifts and lifting systems for individuals with mobility disabilities. This includes devices that assist in transferring people from a wheelchair to a bed, shower, or toilet. They offer around ten tailored systems to meet individual needs.
Jan Van der Putten, as Quality and Process Engineer, is closely involved in all matters regarding "regulatory affairs" for Handi-Move’s products. Since each individual product already has a unique identification number (UDI-DI) and serial number (UDI-PI), it is also used for stock management and tracking production from manufacturer to end customer.
Product Information and Identification for the Medical Device Regulation
"For the Medical Devices Regulation (MDR) of the European Commission, we must soon register all our medical devices in a central database called EUDAMED," Jan explains.
The registration of these devices in EUDAMED is done using a Basic UDI-DI. A Basic UDI-DI groups similar products based on their intended use, risk class, design, or characteristics. You can consider this as a grouping of UDI-DIs—unique identification numbers for products. For each Basic UDI-DI, a set of information must be submitted to meet the requirements of the European Commission.
"The advantages of My Product Manager become evident thanks to the already available product data in the platform," Jan shares. "This made the mandatory registration with EUDAMED smooth and structured thanks to My Basic UDI-DI Manager."
"Moreover, we can quickly register our product range because the system allows us to export and import via an Excel file," Jan adds. "This is particularly useful for bulk additions of similar products or product variants."
Collaboration with GS1
Jan has been working with the GS1 system for a year. "Through My Training, I was able to follow a complete learning journey at my own pace on the identification of medical devices using GS1 standards," Jan shares. "The material is thoroughly explained in-depth through online courses, followed by a one-on-one conversation with a GS1 expert for more specific questions."
A lot of data is requested to comply with European regulations, which can make it complex at times. "My Basic UDI-DI Manager has greatly helped us with this," Jan explains. "During the registration process, we first worked in a test environment to publish error-free. In this test environment, My Basic UDI-DI Manager indicates any inconsistencies, so we could correct unnoticed errors and supplement crucial information."
"In addition, GS1 closely follows European directives for UDI-DI and Basic UDI-DI and translates them into My Basic UDI-DI Manager," Jan continues. "We are made aware of this through the data quality report. This allows us to quickly and easily comply with the legislation and implement it into our data."µ
"Despite the complex nature where regulations, ICT platforms, and global sector agreements converge, GS1 Belgilux provided us with individual guidance," Jan shares. "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," Jan states.
"So, join GS1 as soon as possible and follow one of the webinars about My Basic UDI-DI Manager to more easily comply with European regulations," Jan concludes.
