| Theme | EUDAMED |
| Target Audience | Economic operators, Notified Bodies, Sponsors, Member States, European Commission |
| Products concerned | IVDs |
| Documents mentioned |
Regulation (EU) 2017/746 Art. 113 (3) (f) |
This document presents in table form each article of Regulation (EU) 2017/746 that requires an action in EUDAMED, and provides it with an alternative solution until the database is fully operational. The economic operator concerned by the action is also identified.
As a reminder, in March 2020, the European Commission announced that it would put the EUDAMED modules into operation as and when they were ready. The latest information provided foresees full functionality by Q2 2024 (with mandatory use of all modules for Q2 2026).