MDCG revises Eudamed SS(C)P position paper for the post-mandatory-use period

What happened

On 30 October 2026 the European Commission's DG SANTE announced that the Medical Device Coordination Group (MDCG) has published a new revision of its position paper on managing the Summary of Safety and (Clinical) Performance (SS(C)P) in Eudamed after use of the system becomes mandatory.

The record available to us confirms the publication and its subject, but not the detail. It does not say which sections changed, what the revision replaces, or whether it alters expectations for manufacturers or notified bodies. Those points are not yet known from our sources, and teams should read the paper itself before drawing conclusions.

Why it matters

The SS(C)P is the public-facing safety and performance document for higher-risk devices. Under the MDR it applies to implantable and class III devices, with exceptions such as custom-made and investigational devices. Under the IVDR it applies to class C and D devices, other than performance-study devices. The notified body validates it, and the intended route to public availability is Eudamed.

Once Eudamed is mandatory, the SS(C)P stops being a document handled mainly through a manufacturer's own website and notified-body exchanges. It becomes a managed record inside a regulated database. Questions about who uploads it, how updates and new versions are handled, and how it links to the device and certificate data stop being theoretical. A position paper on exactly this stage is therefore operationally relevant, and a revision signals that the MDCG's earlier thinking needed updating.

Regulatory context

A position paper from the MDCG is guidance, not law. It reflects the shared view of Member State authorities and the Commission on how to apply the regulations, and notified bodies and competent authorities tend to follow it in practice. Manufacturers who diverge from it should expect to justify the choice.

The revision is also a reminder that SS(C)P management cuts across several workstreams: technical documentation, clinical evaluation or performance evaluation, notified-body review, and database registration. The record does not say how the revised paper treats any of these interfaces.

Other items from the same day show a similar theme, namely regulators tightening how structured information moves through shared systems. Italy's AIFA reminded marketing authorisation holders to complete the medicinal product and active substance fields uniformly in E2B(R3) ICSRs, because automatic mapping of EudraVigilance cases to its national network had run into problems. Austria's BASG reported updated CMDh validation advice, revised RMS request templates for DCP and MRP/RUP, and national requirements now tagged as validation-relevant or not. These concern medicines, not devices, and are unrelated to the MDCG paper. Together they show that when a central system carries regulated content, small inconsistencies in how data is entered or procedures are launched become practical problems, and authorities respond with detailed process guidance.

Who is affected

Manufacturers of MDR class III and implantable devices, and of IVDR class C and D devices, are the most directly affected, along with authorised representatives who handle their registrations. Notified bodies are also in scope, since they validate the SS(C)P. Regulatory and clinical teams who draft and maintain the summaries, and quality teams who own document control and change management, should expect the revision to touch their procedures.

Companies with large legacy portfolios may feel it most. A mandatory-use environment implies that many existing summaries must be managed consistently inside Eudamed. Whether the revised paper offers any transitional approach for them is not stated in the record.

What to watch

The first task is a close read of the revised paper against the current internal procedure for SS(C)P drafting, validation, upload and updates. The second is to see how notified bodies interpret it, since their practical requirements will shape timelines and document formats. Third, watch for any related MDCG or Commission material on Eudamed modules, as the SS(C)P rarely works in isolation from device registration and certificate data.

Until the detail is confirmed, avoid assuming the revision is minor or major. Treat it as a prompt for a gap assessment.