In June 2026, the MDCG published a position paper on the management of the Summary of Safety and Clinical Performance (SSCP) and of Summary of Safety and Performance (SSP) in EUDAMED database following its mandatory use. The MDCG is the European Commission’s Medical Device Coordination Group, which provides advice to facilitate the implementation of the MDR and IVDR.
This paper (MDCG 2026-4) clarifies how these documents – key sources of information on the safety and clinical data of medical devices – will be managed in practice in light of the deployment of the EUDAMED framework.
What is changing: responsibilities to upload the SS(C)Ps
Under the current framework, reflected in MDCG Guidance 2019-9, Notified Bodies are responsible for validating SS(C)Ps prepared by manufacturers during conformity assessment procedures, and for making them publicly available via EUDAMED as part of the certificate registration process. In practice, Notified Bodies upload the validated “master” SS(C)P, together with any subsequent revisions.
The position paper introduces a significant shift to this approach. It revises the guidance to transfer responsibility for uploading SSCPs (for medical devices) and SSPs (for in vitro diagnostic devices) to EUDAMED from Notified Bodies to manufacturers.
Under the updated framework:
- manufacturers will upload the “master” SS(C)P, including translations;
- manufacturers must ensure that the version uploaded corresponds to the one validated during certification;
- Notified Bodies will indicate and confirm in EUDAMED which SS(C)P has been validated in relation to the relevant Basic UDI-DI.
Key deadlines and timeline for implementation
A transitional period is foreseen to support the rollout of the updated SS(C)Ps’ management approach in EUDAMED, allowing stakeholders to adapt their internal processes. The relevant functionalities are expected to become available in:
- July 2026 for the EUDAMED Playground environment
- October 2026 for the EUDAMED Production environment
From 28 May 2026 until full deployment, Notified Bodies will continue uploading SS(C)Ps alongside certificates registrations. As of October 2026, this responsibility will shift to manufacturers, who will upload the documents directly to EUDAMED.
For devices placed on the market before the mandatory use of the UDI/Devices module, manufacturers must upload the corresponding SS(C)Ps in EUDAMED as soon as possible from October 2026, and no later than 27 February 2027.
As notified bodies may continue uploading certificates until 27 May 2027, a temporary misalignment may occur, whereby devices are registered in EUDAMED without a corresponding certificate or linked SS(C)P at the time the manufacturer upload functionality becomes available in the Production environment. The February 2027 deadline is therefore intended to ensure alignment of timelines and the consistent fulfilment of EUDAMED registration obligations.
Do you have questions on how these changes impact your EUDAMED obligations? Contact us here or at mdlaw@obelis.net.
References:
MDCG. (2026). MDCG 2026-4 MDCG Position Paper: Management of SS(C)P in EUDAMED after mandatory use. Retrieved on 23/06/2026.
MDCG. (2022). MDCG 2019-9 Rev.1 – Summary of safety and clinical performance. A guide for manufacturers and notified bodies. Retrieved on 23/06/2026.
MDlaw. (2025). EUDAMED functionality notice officially published. Retrieved on 23/06/2026.
MDlaw. (2026). EUDAMED becomes mandatory on 28 May 2026. Retrieved on 23/06/2026.
MDlaw. (2025). EUDAMED timeline: Actor and device registration. Retrieved on 23/06/2026.
European Commission. (2026). Medical Devices – EUDAMED: Getting ready. Retrieved on 23/06/2026.
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