Idevax simplifies EUDAMED registration of its products with My Basic UDI-DI Manager
As an innovative medical device manufacturer Idevax was looking for an easy way to comply to the Medical Device Regulation and publish their products to EUDAMED. The solution? My Basic UDI-DI Manager. We spoke with Nour Medjdoub, regulatory and clinical affairs specialist at Idevax, about her experience.
About Idevax
Idevax is a Belgian company that develops innovative drug delivery devices for injection with a predefined penetration depth. This patented technology makes it possible to inject more efficiently and more precisely into the different layers of the dermis. The device is easy to use by healthcare professionals and makes an injection very low in pain. Since the skin is very rich of immune cells, the same therapeutic effect can be achieved with up to 1/10th of the usual dose when using VAX-ID. This ensures more sustainable use of valuable medicines and vaccines.
Once their product received a CE marking, Idevax had to comply to the Medical Device Regulation (MDR) requirements and register their products to EUDAMED with Basic UDI-DI’s. To simplify this process, they chose My Basic UDI-DI Manager.
Smooth support for publishing Basic UDI-DI’s
As a pharmacist and responsible for the clinical and regulatory affairs, Nour managed the EUDAMED publication procedure. “We first tried entering the data directly in the EUDAMED platform, but it quickly became clear that we needed support from an intermediary”, says Nour. Thanks to the support of GS1, publication to EUDAMED went quite smoothly.
“Once we validated our product details, the connection with the test environments of My Product Manager and EUDAMED – the so-called ‘playground’ - was done by the GS1 team. There we could check the required data and correct inconsistencies, says Nour. “Then we moved back to the production environment and successfully published our data,” adds Nour.
After publishing all devices to EUDAMED, an issue appeared for the registration of the outer packaging. “GS1 was very reactive and together with EUDAMED, they solved this issue quickly”, adds Nour. “I think investigating and solving this issue ourselves would have taken us a lot more time than it took for GS1,” says Nour. The healthcare team really knows what they are doing and was able to navigate us through EUDAMED.
“Now that we understand the procedure, I am confident that registering the devices still in development will proceed smoothly”, adds Nour.
Transparency as key in the supply chain
All of Idevax’s product data is now available in My Product Manager. “It would be very useful to share this information directly with data recipients such as hospitals and distributors,” says Nour.
“Instead of sending Excel files to each hospital, we are now able to exchange the data automatically. This would improve transparency, which is still a challenge in the healthcare sector”, says Nour.
“Being part of the GS1 network helps us strengthen data sharing across the entire supply chain. And since GS1 is a recognised and international organisation for device identification, we believe that sharing data through My Product Manager is an important evolution – one we want to follow closely in the coming years,” concludes Nour.
