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MDCG publishes new revision of Eudamed SS(C)P position paper for post-mandatory-use period

🇪🇺 European Commission (DG SANTE) · Fri 30 Oct 2026

The Medical Device Coordination Group has issued a revised position paper on managing the Summary of Safety and (Clinical) Performance in Eudamed once the system's use becomes mandatory.

The Medical Device Coordination Group (MDCG) has published a new revision of its position paper on how the Summary of Safety and (Clinical) Performance, known as SS(C)P, is handled in Eudamed after use of the database becomes mandatory. The document is numbered MDCG 2026-4 and was released by the European Commission's Directorate-General for Health and Food Safety on 30 October 2026.

The source available to VigiEye consists only of the document's file listing, giving its title, publication date and author. It does not describe what has changed compared with the earlier version of the paper, so the practical impact of the revision cannot yet be assessed from the information supplied.

By way of context, the SS(C)P is a public-facing summary that manufacturers prepare for certain medical devices and in vitro diagnostic medical devices, and it is intended to be made available through Eudamed, the EU's European database on medical devices.

Manufacturers and notified bodies will want to read the revised paper in full to establish whether it alters expectations for how SS(C)P documents are submitted, validated or updated in the system.

What it means for your team

  • Obtain MDCG 2026-4 and compare it with the previous version of the position paper to identify any changes.
  • Manufacturers of medical devices and IVDs should check whether their SS(C)P submission and update procedures remain aligned.
  • Notified bodies should review any implications for their validation of SS(C)P content in Eudamed.
  • The summary of changes is not available in the source reviewed, so teams should not assume specific amendments until they have read the document.

Official source: European Commission (DG SANTE) ↗

Article written by VigiEye from the official source (European Commission (DG SANTE)). AI-assisted; check the source before acting.

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