MDCG 2026-4: Management of SSCP in EUDAMED after mandatory use, explained
Who uploads the SSCP to EUDAMED after the May 2026 mandatory date — the task moves from notified bodies to manufacturers, with a deadline for devices placed on the market before mandatory use.
This position paper reorganises who uploads the Summary of Safety and Clinical Performance to EUDAMED. Until now the notified body uploaded it while registering certificates; MDCG 2026-4 announces that the task moves to the manufacturer — master version and translations — with the notified body only validating. For devices already on the market, manufacturers must upload their SS(C)Ps no later than 27 February 2027.
Who this applies to
Manufacturers of implantable and class III devices that require an SSCP under MDR Article 32, and of class C and D IVDs that require an SSP under IVDR Article 29 — plus their notified bodies, whose EUDAMED tasks change.
What changes
Until now, the SS(C)P was uploaded by the notified body during certificate registration (Article 32(1) MDR / Article 29(1) IVDR). The position paper announces a rearrangement, to be reflected in a revision of MDCG 2019-9 (SSCP guidance):
Before |
After the change |
|---|---|
Notified body uploads the SS(C)P while registering the certificate |
Manufacturer uploads the SS(C)P — master version and all translations |
Translations handled per MDCG 2021-1 / MDCG 2022-12 workarounds |
Manufacturer manages translations directly in EUDAMED |
No explicit validation marker |
Notified body ticks the box identifying which uploaded SS(C)P it validated, per Basic UDI-DI |
The manufacturer remains responsible for ensuring that the uploaded SSCP is the version the notified body actually validated during certification.
The timeline
- From 28 May 2026 (mandatory use of the first four EUDAMED modules) until the new functionality ships: notified bodies keep uploading master SS(C)Ps (without translations) alongside new and updated certificates.
- The new manufacturer-upload functionality arrives in the EUDAMED Playground environment in July 2026 and in Production in October 2026 — the gap is deliberate, so you can test your process before it counts.
- For devices placed on the market before mandatory use: manufacturers should upload SS(C)Ps as soon as possible and no later than 27 February 2027. The paper notes the practical squeeze — since manufacturer upload only opens in October 2026, the effective window is months, not the original six-month transition.
What this means for you, practically
- Inventory your SS(C)Ps now. Every implantable/class III device (and class C/D IVD) on the market needs its summary — master plus translations — ready for upload well before February 2027.
- Agree the split with your notified body. During the transition the NB uploads masters with new certificates; afterwards you upload and they validate. Misalignment here means missing documents in EUDAMED under your name.
- Use the Playground window. July to October 2026 exists precisely so you can rehearse the upload and validation flow before Production.
- Watch for the MDCG 2019-9 revision. The operative details — formats, translation handling, the validation tick-box — land there, not in this position paper.
Turn templates into working QMS documents.
Start from OpenRegulatory templates, fill them out with AI assistance, and keep them connected to your QMS in Formwork.