New MDCG position paper: what’s changing for SS(C)P management in EUDAMED

The newly published MDCG 2026-4 provides key clarifications on the management of Summary of Safety and (Clinical) Performance (SSCP/SSP) in EUDAMED.

Key takeaways:

• A shift in responsibilities: in the future, manufacturers will be responsible for uploading SS(C)Ps in EUDAMED.
• A transitional period remains in place, during which notified bodies continue uploading “master” versions.
• Important milestones linked to EUDAMED deployment (mandatory use from 26 May 2026, new functionalities expected in the coming months).
• Clarifications also applicable to IVDs (SSP requirements).

This publication reflects the progressive implementation of EUDAMED and the associated regulatory obligations.

Key message: these changes will have a direct impact on regulatory data and certificate management processes.

DOWNLOAD THE POSITION PAPER MDCG 2026-4