Innovative partnership simplify the medical device data management My UDI Manager

Launched in July 2022, GS1 Belgilux’s My UDI Manager pilot project drew the attention of a wider number of companies and start-ups, including Mona.Health. As a company that specializes in the development of artificial intelligence softwares for medical purposes, Mona.Health boarded GS1’s pilot project which is aimed at facilitating the management of its medical devices. In an interview with Mona.Health CEO Olivier Ménage, we found out how the collaboration with GS1 and the use of My UDI Manager has simplified their working processes whilst getting invaluable support.

A company that focuses on health and innovation

Mona.Health’s CEO Olivier Ménage spent his career in the medical equipment industry before he set up his own start-up three years ago. Having trained as a pharmacist and on the strength of his expertise in the field, he headed up the development of artificial intelligence softwares for the preventive detection of eye diseases which may potentially result in blindness.

Using a special camera, a photo is taken of the ocular fundus which is analyzed by artificial intelligence, which allows us to establish whether the patient is at risk of developing diabetic retinopathy or glaucoma.

Regulatory compliance and ease of data exchange

“As a manufacturer of medical devices, we are subject to various regulations. We are currently operating under the MDD (Medical Devices Directive) and the MDR (Medical Devices Regulation) in the field of screening solutions for diabetic retinopathy and glaucoma. We are keen to be fully compliant with the MDR legislation in the short term for both software”, Olivier explains.

The MDR legislation requires the data generated to be published (basic UDI) in EUDAMED. To do so, there are two solutions. The first of which is to manually enter each product on the EUDAMED platform. The second solution, as adopted by Mona.Health, is to link the data entered in advance into My Product Manager Share using My UDI Manager. After validation, the data relating to the medical devices are published on EUDAMED.

Meeting GS1 and the My UDI Manager solution

Through their quality assurance partner, Mona.Health got in touch with GS1 to create UDI codes and barcodes.
“Even though we are a start-up that builds software, we found a simple and practical solution in My UDI Manager that is geared to our needs and requirements. Once the operation of the tool is duly understood, creating the BASIC-UDI takes just five minutes”, Olivier tells us.

capture d'écran validation entre My UDI Manager et My Product Manager

The possibility of combining and cross-referencing the data between My Product Manager Share and My UDI Manager makes it easy to rectify any inconsistencies. Moreover, the My GS1 platform offers a centralized location for all applications, which greatly simplifies the management of the products.

GS1 support throughout the process

As the start-up does not have a data management team as such, Mona.Health duly rated the telephone support provided by GS1 Belgilux. Thanks to personalized training and guidance, they managed to overcome the initial hurdles, benefiting from an easy implementation.

“It is important to have standards in place to create a joint reference frame and a database that contains the key data of all the products.”

The final word

Olivier is keen to share his experience with other start-ups that operate in the field of medical devices: “I highly recommend GS1 Belgilux for the easy implementation of My UDI Manager and for its ease of use. The support provided by GS1 throughout the entire implementation process was especially valued.”

Conclusion

The collaboration between Mona.Health and GS1 Belgilux has made it possible to simplify the administrative management for the medical devices of this innovative start-up. Using the My UDI Manager tool has enabled Mona.Health to comply with applicable regulations whilst receiving valuable support. This inspiring story shows how partnerships between companies, big and small, and standardisation organisations is able to advance innovation and progress in the field of healthcare.