EUDAMED: Changes to SS(C)P Management

The MDCG has published MDCG 2026-4 rev.1, a Position Paper addressing the management of SSCPs (Summaries of Safety and Clinical Performance) and SSPs (Summaries of Safety and Performance) in EUDAMED following its mandatory use.

Changes are coming for manufacturers: the revision of MDCG 2019-9 rev.1 foresees that manufacturers will be responsible for uploading the SS(C)Ps validated by the notified body to EUDAMED, along with their translations.

MDCG 2026-4 rev.1 also postpones the deployment of this new functionality from October to December 2026, enabling manufacturers to upload SS(C)Ps to EUDAMED.

A transitional period is planned to allow manufacturers and notified bodies to adapt their internal processes and test the new functionalities before they become available in the Production environment.

For devices placed on the market before the mandatory use of the UDI/Devices module, the MDCG specifies that manufacturers should upload their SS(C)Ps as soon as possible (from December 2026) and no later than 27 March 2027.

This upcoming change makes it essential to anticipate the internal processes required to manage, validate and upload SS(C)Ps in EUDAMED

DOWNLOAD THE GUIDE MDCG 2026-4 rev.1