The introduction of the new EUDAMED functionality for managing Summaries of Safety and Clinical Performance (SSCPs) and Summaries of Safety and Performance (SSPs) appears to have been delayed, with availability in the Production environment now understood to be expected in December 2026, rather than the October 2026 date previously anticipated.
The new functionality is intended to change how these documents are managed within EUDAMED, transferring responsibility for uploading the master summary and its translations from Notified Bodies to manufacturers. Notified Bodies will continue to validate the relevant summary and identify the version associated with the applicable Basic UDI-DI.
What does this mean for manufacturers?
Under the transitional arrangements set out in MDCG 2026-4, Notified Bodies continue to upload the master SS(C)P when registering new or updated certificates until the new functionality becomes available. Manufacturers remain responsible for managing translations under the applicable guidance.
The delay is particularly relevant for manufacturers of devices already placed on the market before mandatory use of the UDI/Devices module. MDCG 2026-4 indicates that these manufacturers should upload the relevant SS(C)Ps as soon as possible once the functionality becomes available, and no later than 27 February 2027.
If the anticipated December deployment proceeds, manufacturers will have a relatively short period to complete the necessary uploads before this deadline. Manufacturers should therefore review their existing SS(C)Ps, ensure that the appropriate validated versions and translations are available, and coordinate with their Notified Bodies to prepare for the transition.
A note of caution
The revised deployment date should not be interpreted as an extension of the existing SS(C)P upload deadline. Unless further guidance is issued, manufacturers should continue planning against the timelines set out in MDCG 2026-4.
Advena will continue to monitor developments and provide further updates as additional information becomes available.
