Following the formal publication of the gradual EUDAMED rollout, the EU Commission has released an updated draft timeline for EUDAMED implementation. It is available here.
The following estimated deadlines are established for gradual EUDAMED rollout:
The timelines are a moving target. As stated in the document, it is a draft file. However, in general, manufacturers should expect that device registration will be required by 2026.
The steps for mandatory use are:
Therefore, if the 1) independent audits are finalized this year, and 2) the M2M guides are issued within the timelines stipulated in the document, then the modules will be on track for publication in the OJEU within the first half of 2025.