MDCG Publishes Position Paper on the Management of SS(C)Ps in EUDAMED After Mandatory Use
The Medical Device Coordination Group (MDCG) has published MDCG 2026-4 – Management of SS(C)P in EUDAMED after mandatory use, clarifying how Summary of Safety and Clinical Performance (SSCP) documents under the MDR and Summary of Safety and Performance (SSP) documents under the IVDR will be managed in EUDAMED following the mandatory use of the platform’s first modules.
The position paper outlines upcoming changes to the responsibilities of manufacturers and Notified Bodies, as well as the transitional arrangements associated with the implementation of new EUDAMED functionalities.
Transfer of SS(C)P Upload Responsibilities
Currently, SSCPs and SSPs are uploaded by Notified Bodies during the certificate registration process in EUDAMED in accordance with Article 32(1) MDR and Article 29(1) IVDR.
However, MDCG explains that MDCG 2019-9 Rev.1 is being revised to assign manufacturers responsibility for uploading validated SSCPs to EUDAMED, including both the master version and the relevant translations.
According to the position paper, manufacturers will remain responsible for ensuring that the uploaded SSCP corresponds to the version validated by the Notified Body during the certification process.
The same approach will also apply to SSPs for IVDs.
Phased Implementation in EUDAMED
MDCG states that the new functionalities will be implemented gradually in EUDAMED after the mandatory use date of the first four modules.
During the transitional period, from 28 May 2026 until the new functionalities become fully available in the EUDAMED Production environment, Notified Bodies will continue to upload SS(C)Ps when registering new certificates, including certificate updates.
During this phase, only the master version of the SS(C)P will be uploaded by the Notified Body, while manufacturers will remain responsible for managing translations in accordance with existing MDCG guidance.
Timeline for New Functionalities
The position paper indicates that the new functionality will first be deployed in the EUDAMED Playground environment, allowing manufacturers and Notified Bodies to test the process before implementation in the Production environment.
According to the planned timeline:
Deployment in the Playground environment: July 2026;
Deployment in the Production environment: October 2026.
The period between the two deployments is intended to allow manufacturers and Notified Bodies to adapt their internal processes and test the new functionality before full implementation.
Devices Placed on the Market Before Mandatory Use
MDCG also highlights specific implications for devices placed on the market before the mandatory use of the EUDAMED UDI/Devices module.
According to the document, because manufacturers will only be able to upload SS(C)Ps directly from October 2026 onwards, the original six-month transition period for device registration is de facto substantially reduced for SS(C)P uploads.
In addition, a 12-month transition period is foreseen for Notified Bodies to upload the corresponding certificates into the Notified Bodies & Certificates module, ending on 27 May 2027.
To support compliance with registration obligations, MDCG states that manufacturers should upload their SS(C)Ps to EUDAMED as soon as possible, and no later than 27 February 2027, for devices placed on the market before mandatory EUDAMED use, while manufacturers and Notified Bodies should align their timelines to fulfil their registration obligations.
Relevance for Medical Device and IVD Manufacturers
The position paper is particularly relevant for medical device and IVD manufacturers subject to SSCP or SSP requirements under the MDR and IVDR.
Key topics addressed include:
New manufacturer responsibilities within EUDAMED;
Management of SSCPs and SSPs;
Coordination between manufacturers and Notified Bodies;
EUDAMED transition timelines;
Certificate and device registration requirements;
Compliance with regulatory deadlines following mandatory EUDAMED use.
For manufacturers, the document provides additional clarity on how SS(C)Ps will be managed in EUDAMED and the actions required to support compliance during the transition period.
