MDCG 2026-4 rev.1 Revises EUDAMED SSCP Upload Dates

The Medical Device Coordination Group (MDCG) has revised its position on the transfer of Summary of Safety and Clinical Performance (SSCP) and Summary of Safety and Performance (SSP) uploads from notified bodies to manufacturers in EUDAMED. The 30 October 2026 announcement links to MDCG 2026-4 rev.1, dated October 2026.

The revised paper plans Production deployment of the manufacturer upload functionality for December 2026 and says manufacturers should upload as soon as possible, and no later than 27 March 2027, for devices placed on the market before mandatory use of the UDI/Devices module. These replace the October 2026 deployment plan and 27 February 2027 target recorded in our analysis of the June position paper.

This is an MDCG-endorsed non-binding position paper. Its cover states that it is not a European Commission document and does not represent the Commission's official position. The March date is an MDCG upload target; the paper does not enact a new statutory deadline. The deployment dates remain plans rather than evidence that functionality is available.

Which workflow is affected?

The paper concerns manufacturers whose devices require an SSCP under Article 32 of the Medical Devices Regulation (MDR), or an SSP under Article 29 of the In Vitro Diagnostic Medical Devices Regulation (IVDR), and their notified bodies. It addresses the uploader, validated version, translations and certificate links.

Sections 1 and 2 describe the current policy of notified bodies uploading summaries when registering certificate information, alongside the revision of MDCG 2019-9 rev.1 that is intended to transfer uploads to manufacturers. Manufacturers would upload both the master document validated by the notified body and its translations. Notified bodies would identify validated summaries, or relevant parts, by ticking the boxes for the corresponding Basic UDI-DIs when registering or linking certificates. Section 2 states that the same procedure will apply to IVDR SSPs.

Keep three registration milestones separate

The two official documents therefore differ by one day on the certificate-transition endpoint. Pure Global analysis: agree the certificate handoff with the notified body using the earlier date stated in the position paper, and resolve the discrepancy before relying on the later diagram date. Neither date substitutes for the manufacturer's March upload target.

Who uploads during the transition?

Section 3 keeps the interim arrangement in place from 28 May 2026 until the new functionality is fully available in Production: notified bodies need to upload master summaries alongside registration of new certificates, including updates, for the devices concerned. Those uploads exclude translations.

Manufacturers manage translations in line with MDCG 2021-1 rev.1 for MDR devices and MDCG 2022-12 for IVDs. The respective Article 32 and Article 29 rows describe making the summary and translations available to the public on request without undue delay, or specifying where they are available. Certificate registration itself does not require uploading translations to EUDAMED.

Practical decisions for regulatory teams

Pure Global analysis: the revised Production plan falls after the November device-registration milestone. Treat device registration, summary upload and notified-body certificate linking as separate work items with named owners.

1. Complete applicable device registrations on their own schedule. Do not treat the later SSCP/SSP target as an extension of the 28 November 2026 device-registration transition.
2. Prepare a record for each affected Basic UDI-DI. Identify the validated master, translations, corresponding certificate, responsible uploader and agreed handoff date. This tracking format is our recommendation, not an MDCG requirement.
3. Retain the interim upload owner until Production is available. Use Playground to test the planned workflow where available; verify the live Production capability before changing procedures.
4. Agree delivery before the March target. Section 4 anticipates device records that do not yet have their corresponding certificate and summary registered. Reconcile those dependencies with the notified body rather than treating an uploaded document alone as a completed handoff.

For the wider regulatory context, see our European Union market page.