MDCG Position Paper on Management of SS(C)P in EUDAMED
On 18 June 2026, the Medical Device Coordination Group (MDCG) published MDCG 2026-4, a position paper clarifying the management of the Summary of Safety and Clinical Performance (SSCP) and Summary of Safety and Performance (SSP) in EUDAMED following the mandatory use of EUDAMED modules.
The paper outlines a significant upcoming change in responsibilities and provides practical guidance for the transition period.
Key Points of MDCG 2026-4
Shift of responsibility to manufacturers
Future guidance will assign responsibility for uploading the SSCP and SSP in EUDAMED directly to manufacturers, including both the master version and all translations.
Notified bodies retain validation role
Notified bodies will confirm the validated SS(C)P(s) within EUDAMED by linking them to the relevant Basic UDI-DI(s) during certificate registration.
Transitional period with current process
Until the new EUDAMED functionality is fully available, notified bodies remain responsible for uploading the master SSCP/SSP when registering certificates.
Phased EUDAMED implementation
- Playground environment: expected July 2026
- Production environment: expected October 2026
Deadlines for legacy devices
Manufacturers should upload SS(C)Ps for devices already on the market as soon as possible and no later than 27 February 2027.
Alignment required between stakeholders
The transition requires close coordination between manufacturers and notified bodies to ensure timely registration and full compliance.
What This Means for the Industry
This position paper introduces a key operational shift by transferring responsibility for SS(C)P management in EUDAMED from notified bodies to manufacturers. It reflects the broader move toward greater manufacturer ownership of regulatory data in EUDAMED, while maintaining notified body oversight for validation.
European Commission Webinar on SS(C)P in EUDAMED
In light of the upcoming EUDAMED functionality for SS(C)P management, the European Commission is organising a dedicated webinar on 2 July 2026 (13:00–17:00 CEST).
The session will be broadcast live via the European Commission's streaming platform and is accessible to all interested participants via the following link: https://webcast.ec.europa.eu/eudamed-sscp-webinar-2026-07-02.
This webinar is expected to provide further insights into the new SS(C)P functionalities in EUDAMED and may be useful for teams involved in EUDAMED, vigilance, and clinical documentation activities.
What Does This Mean for You?
Manufacturers should prepare for direct responsibility for SS(C)P uploads in EUDAMED, including both master documents and translations. Internal processes and timelines should be reviewed to ensure timely upload and alignment with notified body validation, particularly during the transition phase and for legacy devices.