MDCG 2026-4 Sets EUDAMED SSCP and SSP Upload Transition

The Medical Device Coordination Group (MDCG) has published MDCG 2026-4, a position paper explaining how summaries of safety and clinical performance (SSCPs) and summaries of safety and performance (SSPs) are to be managed in EUDAMED after mandatory use of its first four modules began on 28 May 2026.

The paper sets out a transition in which the task of uploading SSCPs and SSPs will move from notified bodies to manufacturers when new EUDAMED functionality becomes available. It also gives manufacturers of devices placed on the market before mandatory use a specific upload date: as soon as possible and no later than 27 February 2027.

MDCG 2026-4 is an MDCG-endorsed position paper, not a European Commission legal act. It states that its views are not legally binding. Its operational instructions and dates should therefore be described as the MDCG position for implementing existing MDR and IVDR obligations, not as a new regulation.

What changes for SSCP and SSP uploads?

Under the current EUDAMED process described by MDCG 2026-4, the notified body uploads the SSCP or SSP while registering certificate information under Article 32(1) of the Medical Device Regulation (MDR) or Article 29(1) of the In Vitro Diagnostic Medical Devices Regulation (IVDR).

MDCG says that guidance MDCG 2019-9 Rev. 1 is being revised so that the manufacturer will upload:

• the master SSCP or SSP; and
• the applicable translations.

The manufacturer will be responsible for ensuring that the uploaded SSCP is the version validated by the notified body during certification. The notified body will identify the validated SSCP, SSP, or relevant parts by selecting the corresponding Basic UDI-DI when registering or linking the certificate. MDCG 2026-4 says the same procedure will apply to SSPs for IVDs.

This creates a handoff rather than an immediate switch on 28 May 2026. The responsible uploader depends on whether the new manufacturer functionality is available in the EUDAMED Production environment.

EUDAMED SSCP and SSP transition timeline

The paper notes that the planned October availability substantially reduces the practical part of the original six-month device-registration transition during which manufacturers can upload SSCPs themselves. It also recognizes that some registered devices may not yet have a corresponding certificate and SSCP or SSP in EUDAMED because notified bodies have a longer certificate transition. This is why MDCG calls for manufacturers and notified bodies to align their timelines.

Who needs to act?

The update is relevant to manufacturers whose devices require an SSCP under MDR Article 32 and manufacturers whose IVDs require an SSP under IVDR Article 29, together with their notified bodies. It is particularly relevant for:

• manufacturers registering devices that were placed on the market before 28 May 2026;
• teams maintaining master SSCP or SSP documents and their translations;
• regulatory operations teams responsible for Basic UDI-DI and device records; and
• notified-body contacts responsible for certificate registration and validation status.

MDCG 2026-4 does not change which devices require an SSCP or SSP, the substantive content of those summaries, or the requirement for notified-body validation. Its focus is who uploads the documents, how the validated version is identified, and how the transition interacts with EUDAMED device and certificate registration.

What should manufacturers do before the handover?

Pure Global recommends turning the position paper into a record-level transition plan:

1. Identify every affected Basic UDI-DI. Link each record to its certificate, master SSCP or SSP, required translations, notified body, and current EUDAMED status.
2. Confirm the validated master version. Establish a controlled method to distinguish the notified-body-validated document from drafts and later working copies.
3. Assign translation ownership. The paper states that manufacturers manage translations in line with the existing EUDAMED transition guidance; certificate registration itself does not require the notified body to upload translations.
4. Agree the handoff with the notified body. Record whether the notified body will complete the interim master-document upload or whether the manufacturer will upload after Production functionality becomes available.
5. Prioritize pre-mandatory-use devices. Work backward from 27 February 2027 and account for the certificate-registration dependency instead of waiting for the final weeks of the transition.
6. Verify the live system before execution. July and October are deployment plans stated in the June position paper. Teams should confirm the current Playground and Production behavior before updating procedures or closing implementation tasks.

A useful control is a portfolio matrix with one row per Basic UDI-DI and fields for the validated master, translations, certificate link, responsible uploader, upload status, and target date. This is Pure Global's implementation recommendation; MDCG 2026-4 does not prescribe a particular tracking format.

Read the complete MDCG 2026-4 position paper. For the wider database rollout, see Pure Global's update on the mandatory EUDAMED modules and May 2026 timeline and our EU MDR consulting overview.