EUDAMED SSCP Upload Function Planned for October 2026: Responsibility Shifts from Notified Bodies to Manufacturers

News: EUDAMED SSCP Upload Function Planned for October 2026 — Responsibility Shifts from Notified Bodies to Manufacturers

Published: 8 October 2026, 13:32 · Category: Registration and Market Access

What is changing

On 18 June 2026, the Medical Device Coordination Group (MDCG) published position paper MDCG 2026-4, “Management of SS(C)P in EUDAMED after mandatory use”, setting out how the management of the Summary of Safety and Clinical Performance (SSCP, under the MDR) and the Summary of Safety and Performance (SSP, under the IVDR) in the database will be adjusted after mandatory use of EUDAMED.

The core change can be summarised in one sentence: the task of uploading the SS(C)P to EUDAMED moves from the notified body to the manufacturer.

The nature of the document should be noted: it is an MDCG position paper, not a European Commission document, and it does not represent the Commission’s official position; its content is not legally binding. The authority to give a binding interpretation of EU law rests solely with the Court of Justice of the European Union.

Current practice

Under the current framework (guidance MDCG 2019-9), the SSCP is drawn up by the manufacturer, confirmed by the notified body during conformity assessment, and then uploaded to EUDAMED by the notified body when registering certificate information, so that it is available to the public.

MDCG 2026-4 states that from 28 May 2026 (the date on which the first four EUDAMED modules became mandatory) until the new function is fully available in the EUDAMED production environment, notified bodies must continue to upload the relevant device’s SS(C)P when registering new certificates and their updates. This step concerns only the master version and does not include the language translations.

The adjusted approach

MDCG 2019-9 rev.1 is being revised so that the upload is performed by the manufacturer. According to the position paper:

• The manufacturer is responsible for uploading the notified-body-confirmed master SSCP and its translations (pursuant to Article 29(4) of the MDR).
• The manufacturer must ensure that the version uploaded is the version confirmed by the notified body during certification.
• The notified body then indicates in EUDAMED, by ticking the corresponding Basic UDI-DI, which SS(C)P has been confirmed.

The same mechanism applies to the SSP for IVDs.

Translation management continues to follow the existing guidance: MDCG 2021-1 rev.1 under the MDR and MDCG 2022-12 under the IVDR.

Timeline and transition period

The new function will first be deployed to the EUDAMED Playground test environment and, several months later, to the production environment. The document notes that the Playground deployment is planned for July 2026 and the production deployment for October 2026. The interval between the test and production deployments is the time left for manufacturers and notified bodies to adjust internal processes and run trials in the test environment.

For legacy devices placed on the market before mandatory use of the UDI/Device module, the document states that manufacturers should upload the corresponding SS(C)P as soon as possible and no later than 27 February 2027. The document also highlights a practical gap: the original device registration transition period was six months, but because manufacturers cannot upload the SS(C)P until after October 2026, that transition period is in practice substantially compressed for the SS(C)P upload step. At the same time, notified bodies have a 12-month transition period for uploading certificates in the Notified Bodies & Certificates module, which ends on 27 May 2027. Consequently, when the new function goes live, there may still be a considerable number of registered devices for which the corresponding certificates and SS(C)P have not yet been recorded.

Sources and scope

Sources:

• Medical Device Coordination Group (MDCG) position paper MDCG 2026-4, “MDCG Position Paper: Management of SS(C)P in EUDAMED after mandatory use”, published 18 June 2026: https://health.ec.europa.eu/document/download/a80332cf-e9f0-4d45-8863-3d96e8c2a675_en?filename=mdcg_2026-4_en.pdf
• European Commission, DG SANTE — MDCG endorsed documents and other guidance: https://health.ec.europa.eu/medical-devices-sector/new-regulations/guidance-mdcg-endorsed-documents-and-other-guidance_en
• European Commission — Medical Devices — EUDAMED: https://health.ec.europa.eu/medical-devices-eudamed_en
• EUR-Lex — Regulation (EU) 2017/745 on medical devices: https://eur-lex.europa.eu/eli/reg/2017/745/oj

Verification scope and access date: this review covered the full text of MDCG 2026-4, the European Commission’s MDCG guidance list page and EUDAMED page, and the entry point for the MDR legal text; the access date was 8 October 2026. All dates cited in this article are taken from the wording of the official documents.

Applicability note: this article is a compilation and interpretation of publicly available regulatory information and does not constitute a compliance conclusion or commitment in respect of any specific product, company or registration application. EUDAMED deployment plans, transition arrangements and deadlines are governed by the official texts and may change with subsequent official updates; actual implementation should be based on the latest publications of the European Commission and the MDCG.

Source list

• Medical Device Coordination Group (MDCG) / European Commission — 18 June 2026
• European Commission, DG SANTE — MDCG endorsed documents and other guidance
• European Commission — Medical Devices — EUDAMED
• EUR-Lex — Regulation (EU) 2017/745 on medical devices

AIMEILI Regulatory Interpretation

The transfer of the SS(C)P upload task is a governance shift rather than a mere IT change: the manufacturer becomes the party responsible for the public-facing SS(C)P content in EUDAMED, while the notified body’s role narrows to confirming, by ticking the relevant Basic UDI-DI, which SS(C)P it has assessed. Manufacturers should therefore treat the SS(C)P as a controlled regulatory record with the same discipline applied to labelling or IFU content.

Three points deserve particular attention:

• Version integrity: the version uploaded must be exactly the version confirmed by the notified body during conformity assessment. Any divergence — including differences introduced by translation, formatting or editorial revision — creates a data-integrity issue and a potential audit finding.
• Translation ownership: under MDCG 2021-1 rev.1 (MDR) and MDCG 2022-12 (IVDR), the manufacturer controls the language versions. This means translation management, linguistic review and version tracking move firmly into the manufacturer’s quality system.
• Legal status: MDCG 2026-4 is a non-binding position paper and does not replace the MDR/IVDR. In practice, however, notified bodies, competent authorities and EUDAMED data users are expected to align with it, so manufacturers should plan on the basis of the described mechanism while monitoring the formal revision of MDCG 2019-9 rev.1.

The deadlines also compound one another. The legacy-device SS(C)P upload deadline of 27 February 2027 is only a few months after the planned October 2026 production release, while the notified body certificate-upload transition runs until 27 May 2027. In that window, EUDAMED may contain device registrations without matching certificates or SS(C)P records — a situation that market surveillance authorities, hospital procurement teams and tender evaluators are likely to query.

Business Impact

• Manufacturers: assign clear internal ownership for SS(C)P uploads (typically regulatory affairs with quality support), update SOPs and work instructions, secure EUDAMED actor access and user rights for the right personnel, and build a controlled translation and version-release workflow before the October 2026 production release.
• Legacy portfolios: the 27 February 2027 deadline requires a consolidated inventory of devices registered before mandatory use of the UDI/Device module, matched against existing SS(C)P master versions and translations; remediation should start now rather than after the production go-live.
• Notified bodies: their workload shifts from uploading documents to confirming SS(C)P versions in EUDAMED, which will require internal process changes and may affect certificate registration timelines.
• Distributors, importers and authorised representatives: public SS(C)P availability in EUDAMED becomes a practical checkpoint for hospital tenders, procurement questionnaires and post-market monitoring; gaps may trigger customer queries and should be anticipated.
• CROs and regulatory consultancies: demand is likely to increase for gap assessments, SS(C)P drafting and translation management, EUDAMED data remediation and legacy-device upload support.
• Compliance risk: publishing an unconfirmed or outdated SS(C)P, or failing to upload by the applicable deadline, can affect conformity assessment outcomes, market surveillance interactions and the credibility of EUDAMED data used by customers and authorities.

Recommended immediate actions: confirm EUDAMED actor roles and access; map all devices requiring an SSCP or SSP; verify that the master versions held internally match those confirmed by notified bodies; prioritise translations for the markets actually served; and set an internal deadline comfortably ahead of 27 February 2027 for legacy devices.