EUDAMED:
Manufacturers to Upload SSCP and SSP Documents Themselves in Future

With its position paper MDCG 2026-4, the Medical Device Coordination Group has announced a significant change to the management of safety and performance reports in EUDAMED. In future, manufacturers will be expected to upload the validated SSCP and SSP documents, including the required translations, directly to EUDAMED. However, the Notified Body will remain involved in the review and confirmation process.

What Is Changing in the SSCP and SSP Upload Process?

Under the current procedure, the “Summary of Safety and Clinical Performance” (SSCP) for medical devices and the “Summary of Safety and Performance” (SSP) for in vitro diagnostic medical devices are uploaded to EUDAMED by the Notified Body.

Although the documents are prepared and updated by the manufacturer, their technical publication in EUDAMED has so far taken place in connection with the registration of the corresponding certificate by the Notified Body.

MDCG 2026-4 now provides for a new allocation of responsibilities:

The manufacturer uploads the master version of the SSCP or SSP directly to EUDAMED.
The manufacturer also uploads the required translations.
The manufacturer must ensure that the uploaded master version corresponds to the version validated by the Notified Body.
The Notified Body confirms in EUDAMED which SSCP or SSP documents, or which parts of them, have been validated.
This confirmation is provided by selecting the associated Basic UDI-DIs when registering or linking the certificate.

The technical and regulatory role of the Notified Body therefore remains in place. The change primarily transfers operational responsibility for uploading and managing the documents in EUDAMED.

Transition Period Until the New EUDAMED Function Is Available

The new function is to be introduced gradually in EUDAMED. According to the schedule outlined in the position paper, it was initially expected to become available in the EUDAMED Playground environment in July 2026. Deployment in the EUDAMED production environment is planned for October 2026.

Until the new function is fully available in the production environment, the existing procedure will continue to apply:

When registering new certificates and corresponding certificate changes, the Notified Body uploads the master version of the SSCP or SSP. During this transition period, the upload by the Notified Body covers only the master version and not the translations.

The period between deployment in the Playground environment and deployment in the production environment is intended to allow manufacturers and Notified Bodies to adapt their internal processes and test the new function.

Special Deadline for Products Already Placed on the Market

For products that were placed on the market before the mandatory use of the EUDAMED UDI/Devices module began on 28 May 2026, MDCG 2026-4 specifies a special transitional arrangement.

As manufacturers are not expected to be able to use the new upload function until October 2026, the original six-month transition period for registering these products is effectively shortened considerably with regard to the SSCP or SSP upload.

In addition, Notified Bodies have a twelve-month transition period, until 27 May 2027, to register certificates that have already been issued. As a result, products may already be registered in EUDAMED while the associated certificate and SSCP or SSP have not yet been entered into the system.

The MDCG therefore recommends that manufacturers upload the relevant documents as early as possible and no later than 27 February 2027. Manufacturers and Notified Bodies should coordinate their timelines at an early stage.

Why Is Responsibility for the Upload Being Transferred to Manufacturers?

MDCG 2026-4 does not specify one single explicit reason for this change. However, several practical and regulatory reasons can be derived from the existing requirements and the official accompanying documents.

Manufacturers are already responsible for preparing, updating and maintaining the content of the SSCP or SSP. This also includes alignment with the clinical evaluation or performance evaluation, the post-market surveillance system, PMCF or PMPF activities and the Periodic Safety Update Report.

Manufacturers are also responsible for the accuracy of the translations. As a general rule, the Notified Body validates the relevant master version, but not every individual translation. Nevertheless, translations previously had to be forwarded to EUDAMED through the Notified Body.

Direct uploading eliminates this administrative intermediate step. At the same time, the SSCP or SSP becomes more closely associated with the device data record managed by the manufacturer and the corresponding Basic UDI-DI.

Less Duplication of Work and Reduced Burden on Notified Bodies

The change must also be viewed in the context of the planned simplification of the MDR and IVDR. The European Commission’s proposal COM(2025) 1023 aims to reduce unnecessary documentation requirements, duplication of work and administrative burdens for manufacturers and Notified Bodies.

The Commission points out that the draft SSCP or SSP is already part of the Technical Documentation submitted to the Notified Body as part of the conformity assessment. An additional separate review and publication process may therefore create avoidable work.

In its cost analysis, the European Commission estimates that the fees charged by a Notified Body for the initial validation of an SSCP or SSP amount to approximately €1,200 to €4,000 per document. The broader legislative proposal therefore even envisages abolishing the separate SS(C)P validation process in the future and reviewing the documents as part of the assessment of the Technical Documentation.

However, this proposed legislative amendment must be distinguished from the EUDAMED process change that has now been announced. MDCG 2026-4 initially transfers responsibility for the upload to the manufacturer, while the Notified Body will continue to confirm the validated version in EUDAMED.

Legal Notice: The MDR and IVDR Have Not Yet Been Amended Accordingly

The currently applicable wording of Article 32(1) MDR still provides that the Notified Body must upload the SSCP to EUDAMED following its validation. Article 29(1) IVDR contains a comparable requirement for the SSP.

MDCG 2026-4 is a non-binding position paper. It describes the planned operational implementation in EUDAMED but does not directly amend the wording of the MDR or IVDR.

The amendment proposal COM(2025) 1023 would establish the manufacturer’s responsibility more clearly in the future. However, it is still progressing through the European legislative procedure and must be adopted by the European Parliament and the Council before the proposed amendments become legally binding.

Manufacturers should therefore distinguish between the announced EUDAMED procedure, the legal requirements that remain applicable and the proposed amendments that have not yet been adopted.

What Manufacturers Should Prepare Now

Manufacturers of affected medical devices and IVDs should adapt their internal processes in good time. This should include, in particular:

Identifying all products and Basic UDI-DIs subject to SSCP or SSP requirements
Defining the persons responsible for uploading and managing the documents
Checking which master version was validated by the Notified Body
Managing validated documents in an audit-compliant manner
Assigning the SSCP or SSP to the correct Basic UDI-DIs
Managing the required language versions
Coordinating upload and certificate deadlines with the Notified Body
Adapting existing SOPs and approval processes
Testing the new function in the EUDAMED Playground environment in good time

Particularly for larger product portfolios, manually uploading numerous documents and translations may require considerable effort. Companies should therefore assess at an early stage how the SSCP and SSP process can be technically supported, monitored and documented in an audit-compliant manner.

Conclusion

With MDCG 2026-4, another significant EUDAMED process is being transferred to the responsibility of manufacturers. The change may shorten coordination processes and simplify the management of translations. At the same time, manufacturers will face new operational responsibilities relating to version control, assignment, uploading and deadline monitoring.

For the time being, the Notified Body will remain responsible for reviewing and confirming the validated version. Manufacturers should therefore prepare both their internal document processes and their cooperation with their Notified Body for the new procedure at an early stage.