NEW YORK – The European Commission this week said that its Eudamed database will become functional by 2024, with manufacturers of medical devices and in vitro diagnostic tests expected to fully transition to using Eudamed by 2026.
It also published guidance for manufacturers on how to operate until the Eudamed database becomes fully functional.
Eudamed is a key feature of the EU’s new In Vitro Diagnostic Regulation. Manufacturers are expected to upload data about their devices to the database, including conformity assessments by notified bodies, performance study data, and post-market surveillance information.
While the database is already partially functional it has been plagued by delays. In 2020, the EU announced it would postpone the full launch of Eudamed until this year. According to its newly announced timeline, it will complete development of all Eudamed modules by the end of 2023.
An auditing period will follow in 2024, and use of the database will become mandatory for IVD makers for clinical investigation, performance study, and market surveillance by the end of that year. By the end of 2026, it will become mandatory for manufacturers to enter unified device identification data as well as notified body certificate data into Eudamed, according to the EU.
The EU also recently staggered the introduction of the IVDR, which began to apply in May. Manufacturers were previously expected to bring their entire catalogs into compliance by May 26, 2022, but a shortage of regulatory capacity compounded by the COVID-19 pandemic made this impossible. Most molecular devices that held a CE-IVD mark prior to the date of application will require clearance by a notified body by May 2026.