MDCG 2026-4 is published: new transitional process for SSCP Management in EUDAMED
The MDCG published MDCG 2026-4 – Management of SS(C)P in EUDAMED after mandatory use in June 2026.
The document explains how SSCP documents will be managed in EUDAMED during the transition following the start of mandatory use on 28 May 2026.
What are the main changes?
Under the current process, SSCPs are uploaded to EUDAMED by Notified Bodies as part of the certificate registration process. However, this is expected to change with the revision of MDCG 2019-9. In the future, manufacturers will be responsible for uploading the master SSCP validated by the Notified Body, together with the relevant translations.
Until the new EUDAMED functionalities are available, Notified Bodies will continue to upload SSCPs. During this period, only the master version will be uploaded; translations will not be included.
The new functionalities are currently planned to become available in the EUDAMED Playground environment in July 2026 and in the Production environment in October 2026. Once these functionalities are available, manufacturers will be expected to upload SSCP documents directly to EUDAMED.
Key transition dates for SSCP uploads
An important point concerns devices placed on the market before the mandatory use date of the EUDAMED UDI/Device module.
For these devices, manufacturers are advised to complete the SSCP uploads as soon as possible, with 27 February 2027 indicated as the deadline.
This means that manufacturers should start reviewing their internal responsibilities for SSCP management and plan the transition together with their Notified Bodies.
The process is not changing overnight, but the direction is clear: manufacturers will have a more active role in managing SSCPs in EUDAMED.
Read more in the Position Paper
Download the MDCG 2026-4 MDCG Position Paper: Management of SS(C)P in EUDAMED after mandatory use.
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