MDCG Position Paper published on Management of SSCP/SSP in EUDAMED

The EU Medical Device Coordination Group (MDCG) has published a new guidance document, MDCG 2026-4, titled ‘MDCG Position Paper: Management of SS(C)P in EUDAMED after mandatory use’.

The document explains that “The summary of safety and clinical performance and the summary of safety and performance (SSCP and SSP respectively), are to be uploaded by the notified body during the process of registering certificates information according to Article 32(1) MDR and Article 29(1) IVDR,” continuing by adding that “This policy is however evolving.”

This evolution includes revision to prior guidance MDCG 2019-9 – rev.1 to assign to the manufacturer the task of uploading SSCPs/SSPs in EUDAMED, including both the ‘master’ version together with any translations, in accordance with MDR Article 29(4). This is currently contrary to MDR Article 32(1) which requires the notified body to upload the SSCP/SSP to Eudamed.

According to the Position Paper, the changes to MDCG 2019-9 – rev.1 will shortly be reflected in EUDAMED and will require the notified body to indicate which is the validated SSCP/SSP by ticking the box(es) corresponding to the relevant Basic UDI-DI(s). This functionality will be available when registering and/or linking to the relevant certificate.

A transitional period will be foreseen to switch the task of SSCP/SSP upload in EUDAMED from the notified body to the manufacturer. Manufacturers should access the new guidance for further information and instructions.