Lionel Tussau

He is leading healthcare initiatives at the product content solution provider atrify (formerly 1WorldSync), both for connections with Regulatory UDI databases (such as EUDAMED) and GDSN projects between manufacturers, wholesalers, GPOs and hospitals. Prior to joining this company 10 years ago, Lionel spent 16 years in the FMCG industry, managing collaborative supply chain projects and implementation of GS1 standards.

We all know that the healthcare landscape is undergoing significant transformation. Today’s patients and clinicians are savvy consumers, demanding access to trusted product information to make informed decisions about health care. In parallel, government organisations are supporting patient safety through regulatory mandates around product traceability. To me, one of the biggest changes on the horizon will be new EU requirements for product information. If you are not already preparing for this major new requirement, start now – the clock is ticking. So where are these new data requirements coming from? The new European Medical Device Regulation (EU MDR) will establish a robust, transparent, predictable and sustainable regulatory framework for medical devices to ensure a high level of health and safety whilst supporting innovation by establishing Eudamed, the European UDI database. On May 25 th 2017, the new EU MDR came into force and replaced the Medical Devices Directive (93/42/EEC) and Active Implantable Medical Devices Directive (90/385/EEC). One year from now, by May 25 th 2019, you need to have updated your technical documentation and processes to meet the requirements. These changes combined with a complex development process for medical devices make the transition a complicated and time-consuming process. As you will may know, the Regulation affects all medical devices sold in the EU. Different timelines apply to the physical labeling of products, based on risk classification. During a period of 18 months after the date of application of Eudamed, the database must be filled with data on the rest of the devices that are placed on the European market. The go-live date for Eudamed is set on March 26, 2020. On that date Eudamed will be functional for medical devices as well as IVDs. From May 26 th , 2020 for medical devices, and May 26 th , 2022 for...