October 2026 EU MDCG Shifts SSCP/SSP Uploads to Manufacturers: Translations Also Manufacturer-Managed, Catch-Up Due by 27 March 2027

EU MDCG Moves SSCP/SSP Uploads to Manufacturers: Translations Also Manufacturer-Managed, Catch-Up by 27 March 2027

On 30 October 2026, the European Commission's Directorate-General for Health and Food Safety published MDCG 2026-4 rev.1, entitled 'MDCG Position Paper: Management of SS(C)P in EUDAMED after mandatory use'. The document is dated October 2026 and runs to only three pages. Its narrow focus is a specific EUDAMED task: who uploads the Summary of Safety and Clinical Performance (SSCP) and the Summary of Safety and Performance (SSP) for in vitro diagnostic medical devices.

The article was published on 1 November 2026 at 19:52 under Registration and Market Access.

A Three-Page Position Paper Changes One Division of Responsibilities

The paper is short, but it changes a practical division of work in EUDAMED: responsibility for uploading the SSCP and the IVD SSP will shift from notified bodies to manufacturers. Manufacturers will need to upload the master version confirmed by the notified body and the translations prepared under MDR Article 29(4). Notified bodies will, when registering certificates, select the version they have confirmed by Basic UDI-DI. The new functionality will first go live in the EUDAMED Playground and then in Production, planned for December 2026. For devices already on the market before mandatory use, manufacturers should complete catch-up uploads no later than 27 March 2027.

Current Practice: Notified Body Uploads

Section 1 of the document sets out the status quo. Under MDR Article 32(1) and IVDR Article 29(1), SSCPs and SSPs are uploaded by notified bodies in the process of registering certificate information. In other words, the summary has been tied to the certificate registration action: manufacturers prepare the content, and notified bodies enter it.

New Approach: Manufacturer Uploads, Notified Body Selects

Section 2 sets out the change. MDCG 2019-9 rev.1 is being revised, and the direction is to assign the upload task to manufacturers: both the master version and the translations in each language prepared under MDR Article 29(4) are to be submitted by manufacturers into EUDAMED. The document also clarifies a responsibility boundary: the manufacturer must ensure that the SSCP uploaded is the version confirmed by the notified body during certification.

Correspondingly, when registering or linking certificates, notified bodies will select, by the relevant Basic UDI-DI, the SSCP they have confirmed (or certain parts of it), still on the basis of MDR Article 32(1). The document states that this approach also applies to SSPs for IVDs.

How the Transition Period Works

Section 3 addresses timing. The new functionality will go live in the coming months, after the mandatory use date, with a transition period in between to move the upload task from notified bodies to manufacturers.

The interim rule during the transition period is as follows: from 28 May 2026, the mandatory use date for the first four EUDAMED modules, until the new functionality is fully available in Production, notified bodies must still upload the corresponding SS(C)P when registering new certificates and their updates, and they should upload only the master version, not translations. Translations are to be handled by manufacturers under MDCG 2021-1 rev.1 and MDCG 2022-12. A footnote adds that certificate registration itself does not require uploading SS(C)P translations.

The new functionality will first go live in the EUDAMED Playground and then, after a few months, in Production. According to the planned dates in the footnote, the Playground is scheduled for July 2026 and Production for December 2026. The interval between the two environments is intended to give manufacturers and notified bodies time to adjust their processes and test in the Playground.

The Real Hard Date Is in Section 4

Section 4 deals with devices already placed on the market before mandatory use of the UDI/Device module. The document acknowledges one consequence: if manufacturers can only upload the SSCP from December 2026, then the six-month device registration transition period originally provided under MDR Article 123(3)(e)(i) and IVDR Article 113(3)(fa)(i) is effectively compressed for SSCP uploads.

A parallel transition period provides that notified bodies have 12 months to enter the corresponding certificates into the Notified Bodies and Certificates module, by 27 May 2027. This means that a group of devices that have already been registered may not yet have the corresponding certificate and the SS(C)P uploaded by the notified body when the new functionality goes live.

The document therefore gives a direct requirement: manufacturers should upload the SSCP as early as possible and, for devices already on the market before mandatory use, no later than 27 March 2027. It also reminds manufacturers and notified bodies to align their timelines so that each can meet its respective registration obligations.

Not Legislation, but the Timeline Is Firm

The first page of the MDCG document includes a disclaimer: it is endorsed by the Medical Device Coordination Group established under MDR Article 103, but it is not a European Commission document and does not represent the official position of the Commission; its content is not legally binding, and only the Court of Justice of the European Union can give a binding interpretation of EU law.

That statement should be read carefully. The document itself does not create obligations; the obligations come from the provisions of the MDR and IVDR. However, the dates given in the document, 27 March 2027 and 27 May 2027, are regulatory milestones for system-level implementation. For individual devices, the consequence of late submission will be reflected in the fact that EUDAMED data are incomplete.

Sources and Scope

Sources: European Commission, DG Health and Food Safety (DG SANTE), news announcement of 30 October 2026, 'New revision of the MDCG Position Paper on the management of SS(C)P in Eudamed after mandatory use', https://health.ec.europa.eu/latest-updates/new-revision-mdcg-position-paper-management-sscp-eudamed-after-mandatory-use-2026-10-30_en; and the document itself, MDCG 2026-4 rev.1, 'MDCG Position Paper: Management of SS(C)P in EUDAMED after mandatory use' (October 2026, 3 pages), https://health.ec.europa.eu/document/download/a80332cf-e9f0-4d45-8863-3d96e8c2a675_en?filename=mdcg_2026-4_en.pdf.

Verification scope and access date: this review checked the above news announcement page and the full text of MDCG 2026-4 rev.1, item by item, including the responsible upload party, the references to MDR Article 32(1) and Article 29(4), IVDR Article 29(1), the 28 May 2026 mandatory use date, the planned months for the Playground and Production environments, and the two dates of 27 March 2027 and 27 May 2027. The access date was 1 November 2026. The provisions and dates cited in the article are taken from the text of that document, not from secondary reporting.

Applicability note: this article is an interpretation of publicly available regulatory information and does not constitute a conclusion or commitment regarding any specific product, company or registration application. MDCG documents are not legally binding. The timing of system functionality is subject to official subsequent notices, and the information may change with subsequent official updates. The original texts of the European Commission and MDCG should prevail.

AIMEILI Regulatory Interpretation

The core regulatory change is not the substantive standard for the SSCP or SSP, but the allocation of operational responsibility in EUDAMED. The manufacturer becomes responsible for uploading the notified-body-confirmed master version and the required translations, while the notified body confirms and selects the version by Basic UDI-DI. The manufacturer must therefore maintain a verifiable link between the certified master SSCP and every language version uploaded. A translation that cannot be traced to the confirmed master version creates a version-control risk, even if the notified body has already confirmed the master version.

For legacy devices, the 27 March 2027 date is the key planning milestone. The 27 May 2027 date for notified-body certificate entry is a separate obligation and should not be treated as the manufacturer's upload deadline. Manufacturers should not wait until the Production release in December 2026 to prepare content, translations and EUDAMED roles; the Playground period from July 2026 is the practical window for testing uploads and aligning with notified bodies.

• Version control: Maintain a controlled record of the notified-body-confirmed SSCP master version and all language versions prepared under MDR Article 29(4).
• Translation governance: Treat regulatory translation as part of the SSCP/SSP lifecycle, with review, approval and update procedures linked to changes in the master version.
• Notified body alignment: Agree with the notified body how the confirmed version and any selected parts will be identified by Basic UDI-DI, and how updates will be coordinated.
• Legacy remediation: Identify devices already on the market before mandatory use, prepare catch-up uploads, and plan completion before 27 March 2027.
• System readiness: Prepare EUDAMED user roles, data and testing plans for the Playground from July 2026 and Production from December 2026.

Business Impact

For manufacturers, the change adds a regulatory-administration and translation-management burden that sits directly on the market-access timeline. Incomplete SSCP/SSP data in EUDAMED may become visible to regulators and other users, and may create follow-up questions during certificate maintenance, surveillance or market-access planning. Distributors and importers may need clearer evidence that SSCP/SSP uploads and translations are under control, while CROs and regulatory affairs teams should include EUDAMED upload coordination and translation lifecycle management in their service scope.

• Manufacturers: Allocate ownership for EUDAMED uploads, translation review and version control, and budget for catch-up work on legacy devices.
• Distributors and importers: Confirm that manufacturers have a plan for SSCP/SSP uploads and translated versions, especially for devices already on the EU market.
• CROs and regulatory affairs teams: Offer coordinated support for notified-body communication, translation control and EUDAMED testing, rather than treating translation as a standalone vendor task.
• Global registration planning: Build the 2026 Playground and Production dates and the 27 March 2027 catch-up deadline into EU market-access and post-market maintenance schedules.