1. Current situation in EUDAMED:
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. This policy is however evolving, as described below.
2. Revision of the guidance MDCG 2019-9 – rev.1 on SSCP:
Guidance MDCG 2019-9 – rev.1 is being revised to assign to the manufacturer the task to upload the SSCPs in EUDAMED, both the ‘master’ version along with the translations
in accordance with Article 29(4) MDR. It is the responsibility of the manufacturer to ensure that the uploaded SSCP is the one validated by the notified body during the certification
process. The changes outlined in the revised guidance will be reflected in EUDAMED and will require the notified body to indicate which is the validated SSCP(s), or parts thereof,
in accordance with Article 32(1) MDR, by ticking the box(es) corresponding to the relevant Basic UDI-DI(s). This functionality will be available when registering and/or linking the
relevant certificate. See the guidance for more details.
This procedure will apply as well to SSP (IVDs).
3. Timeline for implementation in EUDAMED:
Changes will be implemented in EUDAMED in the coming months and after the mandatory use date. A transitional period will be foreseen to switch the task of SS(C)Pupload in EUDAMED from the notified body to the manufacturer.
https://health.ec.europa.eu/latest-updates/new-revision-mdcg-position-paper-management-sscp-eudamed-after-mandatory-use-2026-10-30_en