Why is the current model changing?

From 26 May 2021, in accordance with Article 32(1) of the MDR and Article 29(1) of the IVDR, the obligation to upload SSCPs and SSPs to the EUDAMED database lay with the notified body; this took place during the registration of certificate information.

However, following the mandatory implementation of the first four EUDAMED modules on 28 May 2026, the Commission has decided to restructure this process.

The reason is practical: the manufacturer, rather than the notified body, owns the content of the SSCP and is responsible for its translations; it therefore makes sense to also assign responsibility for uploading the document to the system to the manufacturer.

What does the revision of MDCG 2019-9 rev.1 change?

The ongoing update to the MDCG 2019-9 rev.1 guidelines will assign to the manufacturer the obligation to upload both the “master” version of the SSCP and its translations to EUDAMED, in accordance with Article 29(4) of the MDR.

It will be the manufacturer’s responsibility to ensure that the document in the database is identical to the version verified by the notified body during the certification process.

The notified body will retain a key control function: it will be required to indicate which SSCP (or part thereof) it has validated by ticking the relevant boxes assigned to the relevant Basic UDI-DI, in accordance with Article 32(1) of the MDR. This rule will apply mutatis mutandis to SSPs for IVD devices.

This mechanism introduces a significant change in approach: until now, the notified body was the sole point of entry for data into the system; now, responsibility will be shared between two entities, which requires close coordination between the manufacturer and its certification body.

Timetable

The new functionality in EUDAMED will not be rolled out all at once; the Commission has planned a phased rollout of the changes:

  1. July 2026: the new functionalities will first appear in the EUDAMED Playground test environment, giving manufacturers and notified bodies time to test their internal processes.
  2. October 2026: the same functionalities will be implemented in the EUDAMED production environment, marking the actual start of the new division of responsibilities.
  3. Transition period (28 May 2026 – October 2026): until the new features are fully implemented, notified bodies must continue to upload the master SSCP (without translations) to EUDAMED when registering new certificates and updating them. Translation management remains the responsibility of the manufacturer, in accordance with MDCG 2021-1 rev.1 and MDCG 2022-12.

What does this mean for manufacturers?

For Regulatory Affairs departments, this means one thing: over the coming months, two parallel processes will be in place, and the switchover point must be actively monitored, as the Commission does not envisage automatic notification of the change in responsibility for a specific device.

The Commission clearly sets out the deadline:

  1. Check whether your device was placed on the market before the mandatory use of the UDI/Devices module.
  2. If so, plan to upload the SSCP/SSP by 27 February 2027 at the latest.
  3. Contact the notified body to agree on a joint timetable for the registration of the certificate and the associated document.
  4. Monitor the availability of new features in the Playground environment from July 2026 to test the process prior to production deployment.

It is no coincidence that the deadline of 27 February 2027 precedes the end of the transition period for notified bodies; the Commission expects both parties to synchronise their actions rather than wait until the very last day.

Summary

MDCG 2026-4 is a document which, at first glance, appears to be a technical amendment to the EUDAMED procedure, but in practice shifts the actual administrative responsibility onto manufacturers of medical devices and IVDs.

Companies that have so far treated the SSCP as a “notified body matter” should now review their internal procedures and assign responsibility for uploading the document to a specific individual or team within their Regulatory Affairs department.

Phasing the implementation – Playground in July, production in October – allows time for preparation, but only for those organisations that take action in advance.

Link to the document: MDCG 2026-4 Management of SS(C)P in EUDAMED