As part of our regulatory intelligence platform, we developed an automated redlining tool!
This week, we tackled MDCG 2025-7 Rev. 1 to see exactly what changed between July and December 2025.
The biggest change is the timeline: manufacturers now have more time, a full quarter to be exact! The EUDAMED UDI/Device Registration Module is planned for Q2 2026 (instead of Q1) and the Master UDI/DI for Spectacles is pushed from Q3 2028 to Q4 2028.
The original guidance assumed Q1 2026, so everything downstream shifted to give manufacturers the same buffer period.
Other updates:
- New references to Commission Delegated Regulation 2025/788 and 2025/1920
- Vigilance module timeline updated (now Q2 2027)
- Two new guidance documents referenced (MDCG 2024-14 Rev. 1 and MDCG 2025-8)
The core message stays the same: voluntary early adoption is encouraged, but mandatory dates are now clearer and later than initially planned.