SSCP upload in EUDAMED moves to you: the October 2026 change and the February 2027 date

If you make an implantable or Class III device, or a Class C or D in vitro diagnostic, the job of putting your summary of safety and clinical performance into EUDAMED is moving from your Notified Body to you. The Medical Device Coordination Group set this out in MDCG 2026-4 in June, the function has been in the EUDAMED Playground since the summer, and the Production release is planned for October 2026. For devices already on the market the date to plan around is 27 February 2027.

What the SSCP is and who needs one

Article 32 of the EU Medical Device Regulation (EU MDR) requires a summary of safety and clinical performance (SSCP) for implantable and Class III devices, other than custom made and investigational devices. It is written for the user and, where relevant, the patient, and the Notified Body validates it during conformity assessment. Article 29 of the In Vitro Diagnostic Regulation (IVDR) requires the equivalent summary of safety and performance (SSP) for Class C and D devices. The Commission writes the pair as SS(C)P.

The content rules are in MDCG 2019-9 rev.1 (March 2022). The summary has to be kept current with post market data, so it moves with your clinical evaluation. Our guide to clinical evaluation under the MDR covers how the two documents feed each other.

What MDCG 2026-4 changes

Until now the Notified Body uploaded the validated SSCP to EUDAMED as part of registering the certificate. MDCG 2026-4 reverses that. MDCG 2019-9 is being revised to give the manufacturer the task of uploading the SSCP, the master version and every translation, in line with Article 29(4) of the MDR, which links the summary to the Basic UDI-DI.

Three things follow:

• You register and manage the SSCP. The Playground release notes for version 3.31.2 are explicit. Manufacturers register the summary from a new SS(C)P Management page, select the Basic UDI-DIs it covers, name the Notified Body and mark the master document. Notified Bodies can no longer register new summaries, and ownership of every existing one transfers to the manufacturer.
• The Notified Body confirms what it validated. When it registers or links the certificate, it ticks the Basic UDI-DIs it has validated, and the system sets the version status to validated, partially validated or not validated. It is your responsibility that the uploaded document is the one it approved.
• New versions, inactivation and translations are yours too. A new version breaks the link to the certificate and the earlier validation, so a routine update means going back to your Notified Body for the tick.

What happens until the Production release

From 28 May 2026, when the first four EUDAMED modules became mandatory, and until the new function is fully available in Production, Notified Bodies keep uploading the master SS(C)P alongside new certificates and certificate updates. Translations are not uploaded in this period.

The position paper gives the plan as Playground in July 2026 and Production in October 2026. Playground has happened. As of 1 October 2026 the Commission’s Production release notes do not yet describe the function, so treat October as the planned month and check the EUDAMED release notes before you assume it is live. Our EUDAMED guide has the wider timeline.

Why 27 February 2027 matters

Devices placed on the market before 28 May 2026 have until 28 November 2026 to be registered in the UDI and device module. Because the SS(C)P function only reaches manufacturers in October, the position paper says that six month window is “de facto reduced substantially” for the summary itself.

There is a second knot. Notified Bodies have until 27 May 2027 to upload existing certificates, so when the manufacturer function goes live there will be registered devices with no certificate and no summary behind them. MDCG 2026-4 asks manufacturers to upload the SS(C)P as soon as possible and “no later than 27 February 2027” for devices placed on the market before mandatory use, and to agree the timing with their Notified Body.

That is a guidance date, not a date in the regulation, but it is the one your Notified Body will work to. Treat it as fixed.

What to do this quarter

1. List every Basic UDI-DI that needs a summary. Implantable, Class III, and Class C and D in vitro diagnostics. Our guide to UDI for medical devices explains how the Basic UDI-DI ties the summary, certificate and device records together.
2. Pull the validated version from your Notified Body. The document you upload must be the one it validated, not the latest draft in your file.
3. Get the translations ready. Every language the Member States where you sell accept.
4. Give someone the EUDAMED role. Decide who uploads under your actor registration, and test it in Playground now rather than in Production in February.
5. Agree the sequence with your Notified Body. Which certificates it uploads first, and when it ticks the validation on each Basic UDI-DI.

Where Worldwide Device Solutions fits

Our MDR and IVDR transition service runs from the certificate you hold and the records EUDAMED expects, backed by 500+ CE technical files built and approved and 250+ Notified Body audits delivered. For manufacturers outside the EU we act as EU Authorised Representative from Cork.

If you are not sure which of your devices need a summary, which version your Notified Body validated, or whether you can meet February, book a free twenty minute consultation and Paul will tell you where you stand. For the full picture, start with the fixed fee Gap Assessment.