What Changes
MDCG 2026-4, dated June 2026, is a position paper endorsed by the Medical Device Coordination Group on managing the Summary of Safety and Clinical Performance (SSCP) and the Summary of Safety and Performance (SSP) in EUDAMED after the first four modules became mandatory. Article 32(1) MDR requires an SSCP for implantable and class III devices, other than custom-made or investigational devices. Article 29(1) IVDR requires an SSP for class C and D devices, other than devices for performance studies. The paper changes who uploads the document. It does not change who validates it.
Under both articles the notified body validates the draft summary and then uploads it to EUDAMED, which MDCG 2026-4 places in the process of registering certificate information. MDCG 2026-4 says guidance MDCG 2019-9 rev.1 is being revised to give the upload task to the manufacturer. The notified body will then indicate in EUDAMED which SSCP, or which parts of it, it validated.
Who Uploads What, Before and After
Once the new functionality is live in Production, the tasks split as follows.
| Task | Current State | After MDCG 2026-4's New Functionality |
|---|---|---|
| Uploading the master SSCP / SSP | Notified body, alongside certificate registration | Manufacturer |
| Uploading SSCP / SSP translations | Managed by the manufacturer, in line with MDCG 2021-1 rev.1 (SSCP) and MDCG 2022-12 (SSP) | Manufacturer (unchanged) |
| Confirming which SSCP / SSP, or which parts of it, are validated | Notified body validates the draft, then uploads it (Article 32(1) MDR) | Notified body, by ticking the box for each relevant Basic UDI-DI when registering or linking the certificate |
| Ensuring the uploaded SSCP matches the validated version | Not addressed by MDCG 2026-4 for the interim period | Manufacturer's responsibility |
MDCG 2026-4 traces the notified body's current upload duty to Article 32(1) MDR, and to Article 29(1) IVDR for the SSP, and bases the manufacturer's future upload task on paragraph 4 of MDR Article 29. The manufacturer still draws up the SSCP and the notified body still validates it, as Article 32(1) MDR requires.
The Playground to Production Timeline
MDCG 2026-4 foresees a transitional period for moving the upload from the notified body to the manufacturer. The dates below come from the paper itself.
| Date | What Happens |
|---|---|
| May 28, 2026 | Mandatory-use date for EUDAMED's first four modules. From this date until the new functionality is live in Production, notified bodies continue uploading the master SS(C)P alongside new certificate registrations and updates. |
| July 2026 (planned) | New manufacturer-upload functionality becomes available in the EUDAMED Playground environment, for testing. |
| October 2026 (planned) | New functionality becomes available in the Production environment. Manufacturers can begin uploading SSCPs and SSPs from this point. |
| No later than February 27, 2027 | Date by which MDCG 2026-4 says manufacturers should upload the SSCP or SSP of devices placed on the market before mandatory use. |
| May 27, 2027 | End of the transition period that MDCG 2026-4 describes as 12 months for notified bodies to upload the corresponding certificates into the Notified Bodies & Certificates module. |
MDCG 2026-4 gives the July and October 2026 dates in a footnote as planned deployments. Check the Commission's current EUDAMED announcements before treating October as certain.
Why the Upload Window Is Short
For devices already on the market that are still being placed on it, MDR Article 123(3) sets the November 27, 2026 EUDAMED deadline, six months after the May 28, 2026 mandatory-use date. MDCG 2026-4 calls this the original transitional period of 6 months for device registration.
Manufacturers can only start uploading SSCPs once the Production functionality goes live, planned for October 2026. That leaves less than two months before November 27, 2026. MDCG 2026-4 says the 6-month period is therefore "de facto reduced substantially" for SS(C)P upload.
There is a second gap. MDCG 2026-4 describes a further 12-month transition period for notified bodies to upload the corresponding certificates into the Notified Bodies & Certificates module, ending May 27, 2027. Because of that gap, MDCG 2026-4 notes there may be a significant number of devices registered in EUDAMED that do not yet have a corresponding certificate, and therefore no SSCP, registered by the notified body when manufacturer SSCP upload becomes available. The paper therefore says manufacturers should upload SS(C)Ps as soon as possible, and no later than February 27, 2027, for devices placed on the market before mandatory use.
What Manufacturers Should Do Now
- Do not wait for manufacturer-side upload to open before preparing the SSCP or SSP itself. If the validated master document and its translations are ready, the upload can happen as soon as the Production functionality is live.
- Confirm with the notified body which SSCP or SSP version it validated during certification, since the manufacturer is responsible for uploading that exact version, not a later internal draft.
- Watch the Commission's EUDAMED announcements for confirmation that the Production functionality is live, since MDCG 2026-4 gives October 2026 as a planned date.
- Treat the February 27, 2027 SSCP upload date from MDCG 2026-4 and the November 27, 2026 device-registration deadline as two separate tracking items. A plan that merges them can mark a device as done once it clears the earlier date.
Common Misconceptions
| Misconception | What MDCG 2026-4 Actually Says |
|---|---|
| SSCP upload responsibility shifted to manufacturers immediately when EUDAMED's first four modules became mandatory on May 28, 2026 | No. Notified bodies keep uploading the master SS(C)P until the new manufacturer functionality is live in Production, planned for October 2026 |
| Once manufacturers can upload SSCPs, notified bodies are out of the process | No. The notified body keeps the validation role, confirming which SSCP or SSP version is the validated one by ticking the box for each relevant Basic UDI-DI |
| The SSCP deadline is the same as the EUDAMED device-registration deadline | No. Registration data for devices that were already on the market and are still being placed on it from May 28, 2026 is due November 27, 2026. MDCG 2026-4 says the SSCP or SSP of devices placed on the market before mandatory use should be uploaded no later than February 27, 2027 |
| Every registered device will already have its SSCP in EUDAMED when manufacturer upload opens | No. MDCG 2026-4 expects there may be a significant number of registered devices without a certificate and SSCP in EUDAMED at that point, because notified bodies have until May 27, 2027 to upload certificates |
MDCG 2026-4 does not address what an SSCP or SSP must contain. It moves the upload in EUDAMED from the notified body to the manufacturer and gives February 27, 2027 as the latest upload date for devices already on the market. Put that date in the project plan as its own line, next to November 27, 2026.
Frequently Asked Questions
What does MDCG 2026-4 actually change about SSCP uploads in EUDAMED?
MDCG 2026-4 is an MDCG position paper dated June 2026. It says guidance MDCG 2019-9 rev.1 is being revised so that the manufacturer, not the notified body, uploads the Summary of Safety and Clinical Performance (SSCP) to EUDAMED. The same applies to the Summary of Safety and Performance (SSP) for IVDs. The manufacturer will upload the master version and its translations, and must make sure the uploaded version is the one the notified body validated during certification.
Who uploads the SSCP before the new functionality is available?
According to MDCG 2026-4, the notified body, until the new manufacturer-upload functionality is fully available in the Production environment (planned for October 2026). The paper says that from May 28, 2026, the mandatory-use date for EUDAMED's first four modules, until that point, notified bodies need to continue uploading the master SS(C)P alongside registering new certificates and certificate updates. The notified body uploads the master only. The manufacturer handles translations in that period, in line with MDCG 2021-1 rev.1 and MDCG 2022-12.
When does manufacturer SSCP upload become available in EUDAMED?
MDCG 2026-4 gives a planned rollout of July 2026 for the EUDAMED Playground environment and October 2026 for Production. The paper says the interval between the two is meant to give manufacturers and notified bodies time to adapt their internal processes and test the functionality in Playground.
What is the February 27, 2027 upload date in MDCG 2026-4, and how is it different from the November 27, 2026 EUDAMED deadline?
They cover separate obligations. Under MDR Article 123(3), November 27, 2026 is the deadline for entering the registration data of devices (other than custom-made devices) that were on the market before the May 28, 2026 mandatory-use date and are still being placed on the market from that date. February 27, 2027 is the date by which MDCG 2026-4 says manufacturers should upload the SSCP or SSP of devices placed on the market before mandatory use. A device can be registered by the first date and still be expected, under MDCG 2026-4, to have its SSCP uploaded by the second.
Does MDCG 2026-4 apply to IVDs as well as medical devices?
Yes. MDCG 2026-4 states the same upload procedure applies to the Summary of Safety and Performance (SSP), which Article 29(1) IVDR requires for class C and D devices. Under that article the notified body currently uploads the SSP after validating it.
Is MDCG 2026-4 legally binding?
No. Its cover page states that the views it expresses are not legally binding, and it does not amend the MDR or IVDR. It bases the manufacturer's upload task on Article 29(4) MDR, which requires the manufacturer, before placing a device other than a custom-made device on the market, to enter or verify the Annex VI Part A Section 2 information (except Section 2.2) in EUDAMED and keep it updated.