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MDCG Position Paper: Management of SS(C)P in EUDAMED after mandatory use

The Medical Device Coordination Group (MDCG) has published MDCG 2026-4: Management of SS(C)P in EUDAMED after Mandatory Use, providing guidance on how Summary of Safety and Clinical Performance (SSCP) and Summary of Safety and Performance (SSP) documents will be managed in EUDAMED following the mandatory use of the first EUDAMED modules.

The position paper outlines the transition of SS(C)P upload responsibilities from notified bodies to manufacturers and establishes implementation timelines for the new EUDAMED functionalities.

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