When Should SS(C)P Translations be Uploaded to EUDAMED?

MDCG 2026-4 rev. 1 states that manufacturers should upload the SS(C)Ps for devices placed on the market before the UDI/Devices module became mandatory as soon as possible, and no later than 27 March 2027. The new procedure includes the master version and its translations and depends on a new EUDAMED feature due to be released in December 2026. The date of 27 March 2027 is set out in MDCG guidance; it is not a new statutory deadline under the MDR or IVDR.

To establish precisely when SS(C)P translations should be uploaded to EUDAMED, it is important to distinguish between three issues: the obligation to publish the summary, what the MDCG guidance currently says about its language versions, and the implementation timeline for the new system.

For the purposes of this article, SS(C)P refers to both the SSCP, the Summary of Safety and Clinical Performance under the MDR, and the SSP, the Summary of Safety and Performance under the IVDR. MDCG 2026-4 rev. 1 uses the collective abbreviation SS(C)P.

What changes with MDCG 2026-4 rev. 1

MDCG 2026-4 rev. 1, on the management of SS(C)Ps in EUDAMED, published in October 2026, explains that responsibility for uploading the summaries is transferred from the notified body to the manufacturer. Under the new procedure, the manufacturer will upload both the master version and its translations.

The notified body will retain its validation role. When registering or linking the certificate, the notified body will identify the validated SS(C)P, or the relevant sections, by ticking the boxes associated with the Basic UDI-DI. The manufacturer, in turn, must ensure that the uploaded version matches the one validated by the notified body during the certification process. This procedure will also apply to SSPs for in vitrodiagnostic devices.

This distinction is important for your quality management system: uploading a document and validating its content are two separate processes. The new division of responsibilities requires publication to be coordinated with the notified body, but it does not make the manufacturer a substitute for the notified body in terms of regulatory validation.

When to upload SS(C)P translations: transition timeline

The October revision schedules the new EUDAMED functionality to go live in December 2026. Until it is fully available, the interim procedure remains in place, as described in MDCG guidance 2026-4 rev. 1.

The deadline of 27 March 2027 applies to devices placed on the market before the UDI/Devices module became mandatory and for which an SS(C)P is required. It should not be interpreted as general permission to postpone the upload of any summary for a new device until March.

Sources: MDCG 2019-9 rev. 1 and MDCG 2026-4 rev. 1.

At the time of writing, December remains only an expected date for the new functionality. The fact that instructions are available for adding translations in the EUDAMED testing environment does not, in itself, demonstrate that the functionality has gone live in production.

MDR and IVDR requirements

Article 32 of Regulation (EU) 2017/745 (MDR) requires an SSCP for implantable devices and class III devices, with the exception of custom-made and investigational devices. Article 29 of Regulation (EU) 2017/746 (IVDR) requires an SSP for class C and D devices, except those intended for performance studies.

Both articles require the summary to be understandable to the intended user and, where appropriate, to the patient, and to be made publicly available through EUDAMED. Under the wording of these provisions, the notified body is responsible for validating the summary and then uploading it to EUDAMED. These articles do not set a specific deadline for uploading translations or list the languages in which they must be provided. The linguistic and operational details are set out in the MDCG guidance documents.

MDCG 2026-4 rev. 1 describes how the procedure is evolving, drawing on Article 29(4) in the case of the MDR. However, MDCG guidance does not amend the Regulation: its interpretations are not legally binding and do not constitute an official position of the Commission.

Furthermore, “devices already placed on the market” does not necessarily mean “legacy devices”. Specifically, MDCG 2021-25 rev. 1 on legacy devices states that Article 32 of the MDR does not apply to legacy devices remaining under the directives’ transitional regime. Before arranging translations, you should confirm which of your devices are required to have a summary.

What to do while translations cannot be uploaded

During the interim period, the notified body uploads only the master version when registering new certificates or updates. MDCG 2026-4 rev. 1 expressly clarifies that registering the certificate does not require translations to be uploaded.

This does not remove the need to make the information available to the public. The guidance refers to MDCG 2021-1 rev. 1 for MDR devices and to MDCG 2022-12 for IVDR devices. These guidelines provide for the summary to be made available upon request, without undue delay, or for details to be given on where it can be accessed publicly.

The practical recommendation, therefore, is to prepare the language versions and establish a channel for providing them while waiting for the new functionality to become available.

Which languages and deadlines are covered by MDCG 2019-9 rev. 1

MDCG 2019-9 rev. 1 on the SSCP is still listed as the published version in the official catalogue consulted. MDCG 2026-4 rev. 1 announces a revision to reflect the new division of responsibilities. Therefore, its instructions on uploading summaries should be read alongside the latest transitional provisions.

In terms of language requirements, the guidance recommends translating the SSCP into the languages accepted in the Member States where the device is intended to be placed on the market. The MDR does not explicitly mention translation, but the guidance infers this requirement from Article 32(1), which requires the summary to be clear to the intended user and, where appropriate, to the patient. For the section intended for patients, the guidance refers to the languages required for the instructions for use aimed at this group. It does not establish a general obligation to translate it into all the official languages of the European Union. This link makes it advisable to coordinate the SSCP with IFU translation.

The guidance distinguishes between several deadlines that should not be confused:

These timeframes apply to the procedure set out in the guidance. They should not automatically be carried over to the future system, under which the manufacturer will upload the documents directly. Nor does the 90-day deadline constitute blanket permission to enter a new market without the required translation.

Specific features of SSPs for IVDs

MDCG 2022-9 rev. 1 contains the SSP template, which includes the validation language. However, it does not set out translation arrangements equivalent to those in MDCG 2019-9 rev. 1. Therefore, it would not be correct to apply the same 90-day and 15-day deadlines to it. What MDCG 2026-4 rev. 1 does expressly extend to the SSP is the new procedure for uploading it to EUDAMED.

The template distinguishes between content intended for healthcare professionals and content intended for patients or people without a medical background. For self-testing devices, the SSP must be understandable to these users. For other devices, a patient section is included where the manufacturer considers it appropriate to provide this information to patients.

It also provides for specific validation arrangements for certain Class C devices covered by the same certificate: not all draft summaries need to have been validated during the initial assessment. The history must reflect the actual status of each summary. A translation does not become validated simply because it derives from a document linked to a certificate: the notified body validates the master version, not the translations.

When to update translations after their first upload

Initial publication is only the beginning. Article 61(11) of the MDR provides for at least annual updates to the PMCF evaluation report and, where appropriate, the SSCP for class III and implantable devices. Article 56(6) of the IVDR requires the SSP to be updated as soon as possible when necessary. This does not mean the entire document must automatically be retranslated every year.

When the content of the master version changes, you must assess the impact on all its language versions and publish the corresponding updates. MDCG 2022-9 rev. 1 also notes that updates to the post-market performance follow-up report and the PSUR may require a revision of the SSP.

As a document control measure, we recommend linking each translation to the master version reference, its revision, the Basic UDI-DI, the language and the relevant validation status. This traceability makes it possible to verify which document has been translated and prevents versions from different revisions being published as if they were equivalent.

How to prepare for uploading documents without leaving everything until the last minute

To organise SSCP translation, start by drawing up an inventory of the devices subject to this requirement, target markets, available summaries and outstanding translations. Next, agree with the notified body on the language in which the master version will be validated and how you will coordinate publication.

As part of the quality management system, it is advisable to assign responsibility for approving translations, checking that they correspond to the master version and verifying that they have been uploaded correctly. MDCG 2019-9 rev. 1 assigns responsibility for the accuracy of translations to the manufacturer; the notified body does not validate the translated versions.

If you are wondering when SS(C)P translations need to be uploaded to EUDAMED, use 27 March 2027 as the planning date specified in MDCG 2026-4 rev. 1 for devices falling within this category. Prepare to upload the documents as soon as the new functionality becomes available and, before doing so, check the announced revision of MDCG 2019-9 rev. 1 and the EUDAMED instructions.

At AbroadLink, as a medical and medical device translation company, we can help you plan language versions and their updates. If you have several summaries outstanding, we can review the languages, volumes and timelines with you to prepare a proposal tailored to your devices.