MDCG 2026-4: Who Uploads SSCP and SSP to EUDAMED, the Handover, and 2027 Clocks
MDCG 2026-4 EUDAMED SSCP and SSP upload guide: NB interim duties, manufacturer handover in October 2026, Article 32 vs 29(4), and the 27 February 2027 clock.
For regulatory affairs managers, Persons Responsible for Regulatory Compliance (PRRC), and EUDAMED coordinators of Class III and implantable MDR devices — and of Class C and D IVDs — the live question is no longer whether a Summary of Safety and Clinical Performance (SSCP) or Summary of Safety and Performance (SSP) must exist. It is who uploads that already-validated file into EUDAMED, who owns the translations, and which 2026–2027 clock actually applies.
Under the letter of Regulation (EU) 2017/745 (MDR) Article 32(1) and Regulation (EU) 2017/746 (IVDR) Article 29(1), after validating the summary the notified body shall upload it to Eudamed. MDCG 2019-9 Rev.1 (March 2022), still published on 5 September 2026, still states that the notified body is the only actor that can manage SSCPs in Eudamed.
In June 2026 the Medical Device Coordination Group endorsed MDCG 2026-4 (MDCG Position Paper: Management of SS(C)P in EUDAMED after mandatory use). Paragraph 1 of that paper says the current EUDAMED practice remains notified-body upload during certificate registration, and then adds: "This policy is however evolving."
Direct answer. MDCG 2026-4 is an MDCG-endorsed position paper under MDR Article 103. It is not a European Commission document, not a statutory amendment of MDR Article 32(1) or IVDR Article 29(1), and not legally binding; only the Court of Justice of the European Union can give binding interpretations of Union law. It does not change which devices need an SSCP or SSP, does not rewrite the MDCG 2019-9 template, and does not remove notified-body validation.
Until manufacturer-upload functionality is fully available in the EUDAMED Production environment, notified bodies still upload the validated master SS(C)P with new certificates and certificate updates, without translations. Manufacturers manage translations under MDCG 2021-1 Rev.1 (MDR) and MDCG 2022-12 (IVDR).
Footnote 2 of MDCG 2026-4 plans Playground in July 2026 and Production in October 2026. Treat those month labels as planning dates. As of 5 September 2026, official EUDAMED help for SS(C)P management is still filed under notified-body actor topics, and this page does not treat a Playground version stamp as confirmation that the manufacturer-upload control is live in Production.
Once that Production functionality exists, manufacturers upload the validated master and the translations under MDR Article 29(4) / IVDR Article 26(3). The notified body indicates the validated SSCP(s), or parts thereof, under Article 32(1) by ticking the box(es) corresponding to the relevant Basic UDI-DI(s) when registering or linking the certificate. The same procedure applies to IVDR SSPs.
For devices placed on the market before mandatory use of the UDI/Devices module, manufacturers should upload SS(C)Ps as soon as possible and no later than 27 February 2027, aligned with notified-body certificate upload that MDCG 2026-4 dates to 27 May 2027. There is no EUDAMED user fee for the file. Do not count public certificate-search rows as missing SSCPs.
How to write and validate the document remains the job of the SSCP preparation guide. Who files the already-validated PDF after 28 May 2026 is this page.
| Status item | What is true as of 5 September 2026 |
|---|---|
| MDCG 2026-4 | June 2026 position paper; not a Commission act; not a repeal of Article 32(1) MDR or Article 29(1) IVDR |
| Current statute | After validation, the notified body shall upload the SSCP/SSP |
| MDCG 2019-9 Rev.1 | Still published; still names the notified body as the only EUDAMED SSCP actor; 2026-4 says it is being revised |
| Interim until Production functionality | Notified body uploads master only, without translations; manufacturer owns translation management |
| Planning dates | Playground July 2026; Production October 2026 — re-verify against live EUDAMED environments |
| Manufacturer backstop | Should upload as soon as possible, and no later than 27 February 2027, for devices placed on the market before mandatory UDI/Devices use |
| Notified-body certificate clock | 12-month certificate-upload transition ending 27 May 2027 |
| Public certificate search | 25 July 2026 extract: 3,937 latest-version rows, no SSCP column — not an SSCP census |
Is MDCG 2026-4 a New Transparency Law, or a Position Paper on Who Uploads an Already-Required SSCP or SSP?
MDCG 2026-4 was endorsed by the Medical Device Coordination Group established under MDR Article 103. Page 1 carries the standard MDCG notice: the paper is not a European Commission document, it cannot be regarded as reflecting the official position of the Commission, and the views expressed are not legally binding.
| Layer | Instrument | Legal status | What it decides for SS(C)P upload |
|---|---|---|---|
| Binding statute | MDR Article 32(1); IVDR Article 29(1) | Union regulations | After validation, the notified body shall upload the summary to Eudamed. Unchanged by 2026-4. |
| Binding statute | MDR Article 29(4); IVDR Article 26(3) | Union regulations | Manufacturer enters or verifies device information in Eudamed (Annex VI Part A Section 2 except 2.2) and keeps it updated. 2026-4 maps manufacturer file upload to this duty. |
| Binding Commission act | Commission Decision (EU) 2025/2371 | OJEU 27 November 2025 | First four EUDAMED modules declared functional. The Commission EUDAMED overview and MDCG 2026-4 both date mandatory use of those modules as 28 May 2026. |
| Position paper | MDCG 2026-4 (June 2026) | Non-binding MDCG consensus | Evolving operational handover: manufacturer will upload master plus translations; notified body ticks Basic UDI-DI boxes. |
| Standing SSCP guide | MDCG 2019-9 Rev.1 (March 2022) | Non-binding guidance, still published | Template, readability, validation, and the still-indexed "only actor" upload sentence. 2026-4 says this guide is being revised; the revision is not yet listed on the MDCG guidance index. |
MDCG 2026-4 does not alter the device scope:
- MDR Article 32(1): SSCP for implantable devices and Class III devices, other than custom-made or investigational devices.
- IVDR Article 29(1): SSP for Class C and Class D devices, other than devices for performance studies.
It also does not rewrite Article 32(2) / Article 29(2) content lists, and it does not replace MDCG 2022-9 Rev.1 as the IVDR SSP template. Content and validation stay on the SSCP 101 and the notified-body deficiency pack. This paper decides who pushes the file.
| Dimension | MDR / IVDR | MDCG 2019-9 Rev.1 (March 2022) | MDCG 2026-4 (June 2026) |
|---|---|---|---|
| Legal status | Binding Union legislation | Non-binding guidance | Non-binding position paper |
| SSCP scope | Class III and implantables (Art. 32) | Template and readability | Scope unchanged |
| SSP scope | Class C and Class D (Art. 29) | Not this guide (see MDCG 2022-9 Rev.1) | Same procedure applies to IVDs |
| Upload actor of record | "the notified body shall upload" | "the only actor that can manage the SSCPs in Eudamed" | Manufacturer will upload master plus translations under Art. 29(4); 2019-9 "being revised" |
| Notified-body role | Validates and uploads | Validates; uploads master with the certificate; uploads translations after the manufacturer supplies them | Validates; ticks Basic UDI-DI box(es) when registering or linking the certificate |
| Translations | Languages accepted by the Member States where the device is marketed | Manufacturer drafts; notified body does not validate translations, but 2019-9 still has the notified body upload them | Interim: notified body uploads no translations. After Production functionality: manufacturer uploads them |
| Operational dates | Tied to EUDAMED functionality notices | Written for pre-mandatory EUDAMED | Playground planned July 2026; Production planned October 2026 |
What Did Article 32(1) MDR and Article 29(1) IVDR Actually Assign to the Notified Body, and What Is MDCG 2019-9 Rev.1 Still Telling Google?
Search results and internal SOPs still collide because the statute, the still-published 2019-9 sentence, and the 2026-4 handover are three different instruments.
MDR Article 32(1) states, in relevant part:
"For implantable devices and for class III devices, other than custom-made or investigational devices, the manufacturer shall draw up a summary of safety and clinical performance... The draft of this summary shall be part of the documentation to be submitted to the notified body involved in the conformity assessment pursuant to Article 52 and shall be validated by that body. After its validation, the notified body shall upload the summary to Eudamed."
IVDR Article 29(1) uses the same upload sentence for Class C and Class D: after validation, the notified body shall upload the summary to Eudamed.
MDCG 2019-9 Rev.1, section "Uploading of the SSCP in Eudamed":
"The SSCP shall be uploaded in Eudamed by the NB, which is the only actor that can manage the SSCPs in Eudamed."
That sentence is still on the Commission's public health portal. 2026-4 does not pretend it has already been deleted. It says 2019-9 Rev.1 is being revised to assign the manufacturer the task of uploading both the master version and the translations in accordance with MDR Article 29(4).
Article 29(4) MDR — and the IVDR twin in Article 26(3) — is the manufacturer device-registration duty: before placing a device on the market other than a custom-made device, the manufacturer shall enter or verify in Eudamed the information referred to in Annex VI Part A Section 2 except 2.2, and keep it updated. 2026-4 uses that article as the legal hook for manufacturer file management. It does not rewrite Article 32(1). The remaining Article 32(1) act, in the paper's own words, is the notified body indicating the validated SSCP(s) by ticking Basic UDI-DI boxes when the certificate is registered or linked.
That is a mapping in a non-binding position paper, not a Commission amendment and not a repeal. Competent authorities and notified bodies may still expect involvement consistent with the statute until 2019-9 is actually revised and the Production function exists.
2019-9 also still describes a translation pipeline that 2026-4's interim rules change. Under 2019-9, the manufacturer is responsible for translations once the master is uploaded; the notified body does not validate those translations, but should upload them in Eudamed within 15 days of receiving them. Paragraph 3 of 2026-4 is stricter for the interim: the notified-body upload with new certificates is the master only, without translations. Do not run the 2019-9 "send the German PDF to the notified body for EUDAMED upload" SOP as if it were the current interim rule.
The paper does not state a detailed IT rationale. The operational friction is still obvious from the two texts: notified bodies validate one language, Member States require others, and every PSUR-driven SSCP update used to return to the notified body as another EUDAMED file job. 2026-4 is the MDCG's answer to that bottleneck. It is not a new clinical-content standard.
UDI account ownership is a different actor question, covered by MDCG 2026-5. Actor, device, and certificate registration remain the EUDAMED 101.
Who Uploads the Master File Versus the Translations Before Production Functionality Is Available?
The expensive error is collapsing three periods into one SOP.
| Period | Who uploads the master SS(C)P in EUDAMED | Who uploads translations in EUDAMED | What the manufacturer still owns offline |
|---|---|---|---|
| Interim: 28 May 2026 until Production manufacturer-upload is fully available | Notified body, alongside new certificates and certificate updates | Nobody, during that notified-body certificate-registration step (footnote 1) | Translation files, version identity, and readiness to upload when Production functionality exists |
| Handover: once Production functionality is available (planned October 2026) | Manufacturer | Manufacturer | Keep the uploaded master identical to the notified-body-validated version |
| Pre-mandate devices: placed on the market before mandatory UDI/Devices use | Manufacturer, from October 2026 onwards if the function exists | Manufacturer | Meet the 27 February 2027 "no later than" date in paragraph 4, aligned with the notified body's certificate work to 27 May 2027 |
The interim (from 28 May 2026 until Production deployment)
Commission Decision (EU) 2025/2371 was published on 27 November 2025. The Commission overview and MDCG 2026-4 both treat 28 May 2026 as the mandatory-use date for Actors, UDI/Devices, Notified Bodies & Certificates, and Market Surveillance. Module-by-module duties for those four modules are in the May 2026 mandatory-registration guide. Do not substitute 26 May 2026 from a notified-body news bulletin.
Paragraph 3 of MDCG 2026-4 then sets the interim SS(C)P rule:
- From 28 May 2026 until the paragraph 2 functionalities are fully available in Production, notified bodies need to upload SS(C)Ps alongside registration of new certificates, including updates, for concerned devices.
- That upload is the master SS(C)P only, without translations.
- Footnote 1: certificate registration does not require SS(C)P translation upload in EUDAMED.
- Manufacturers manage translations in line with MDCG 2021-1 Rev.1 and MDCG 2022-12.
"Concerned devices" means devices that already need an SSCP or SSP under Article 32 / IVDR Article 29. 2026-4 does not expand that list to Class IIa non-implantables or Class A/B IVDs.
The handover (Production functionality, planned October 2026)
Footnote 2: deployment in Playground planned in July 2026 and in Production in October 2026. The interval is intended to let manufacturers and notified bodies adapt processes and test in Playground.
Those are planning labels in a June 2026 position paper. As of 5 September 2026:
- Official EUDAMED Playground technical documentation still listed platform release 3.31.2.
- The public Information Centre topic SS(C)P Management remained nested under notified-body actor help.
- No authentic Commission release note reviewed for this article confirmed that manufacturer SS(C)P upload was already live in Production.
Re-open Playground and Production before rewriting SOPs from "notified body uploads the master" to "manufacturer uploads everything."
Once Production manufacturer-upload is actually available:
- The manufacturer uploads the validated master PDF and the Member State translations that the language rules require.
- The manufacturer must ensure the uploaded master is the version the notified body validated during certification. MDCG 2019-9 still allows strictly editorial modifications without a new validation; clinical, performance, or benefit-risk changes do not.
- 2019-9 still requires the public file to be a searchable, printable PDF. Do not treat machine-to-machine XML used for other EUDAMED modules as the SSCP format.
- Paragraph 4: because manufacturers can only upload from October 2026 onwards, the original six-month device-registration transition is de facto reduced for SS(C)P. There is no extra six-month SSCP window that starts on the Production go-live date.
What Does the Notified Body Still Do: Validation, Certificate Linkage, and the Basic UDI-DI Tick-Box?
MDCG 2026-4 does not take the notified body out of the transparency loop. It changes the remaining Article 32(1) mechanism once the new function exists.
| Step | Actor | What 2026-4 / 2019-9 actually support |
|---|---|---|
| 1. Draft and file | Manufacturer | SSCP/SSP is part of the technical documentation submitted for conformity assessment (MDR Art. 32(1); IVDR Art. 29(1)). |
| 2. Validation | Notified body | 2019-9: the SSCP is validated when the notified body has assessed that the required elements are included, accurately presented, and aligned with the current technical documentation. That is an assessment conclusion, not a separately named "validation certificate" in 2026-4. |
| 3. Interim EUDAMED deposit | Notified body | Master only, with new certificates and updates, until Production functionality. |
| 4. Post-functionality deposit | Manufacturer | Master plus translations, matching the validated version. |
| 5. Indication of the validated file | Notified body | Tick the Basic UDI-DI box(es) when registering or linking the certificate. |
| 6. Certificate not yet in EUDAMED | Both, on two clocks | Paragraph 4 warns that many devices may be registered in EUDAMED without a corresponding certificate and related SS(C)P when manufacturer-upload becomes available. Align the manufacturer's 27 February 2027 file work with the notified body's certificate work through 27 May 2027. |
Validation remains non-delegable
Article 32(1) and IVDR Article 29(1) still require notified-body validation. Typical assessment points — consistency with the CER or PER, residual risks, PMCF, and a layperson section that is actually readable — belong to the deficiency-response pack and the SSCP 101. 2019-9 recommends a readability check on the patient part, for example a test given to lay persons, or another method the manufacturer finds adequate. It does not prescribe Flesch-Kincaid as the legal test.
Do not upload a clinically updated SSCP as if EUDAMED were a manufacturer-only document store. 2019-9 says that if the PSUR renders SSCP information incorrect or incomplete, the SSCP shall be updated and, except for strictly editorial modifications, submitted to the notified body with the PSUR.
The Basic UDI-DI tick-box
Paragraph 2, quoted in full on the operative sentence:
"The changes outlined in the revised guidance will be reflected in EUDAMED and will require the notified body to indicate which is the validated SSCP(s), or parts thereof, in accordance with Article 32(1) MDR, by ticking the box(es) corresponding to the relevant Basic UDI-DI(s). This functionality will be available when registering and/or linking the relevant certificate. See the guidance for more details."
What that sentence supports:
- The tick is how the notified body indicates the validated SSCP, or parts of it, against Basic UDI-DI(s).
- It is available when the certificate is registered or linked.
- Detail beyond that is deferred to the forthcoming 2019-9 revision.
What that sentence does not support: a public specification of the Production screens, automatic database queries, document-identifier matching rules, or a statement that an unticked file "will not satisfy competent-authority audits." Those UI and enforcement details are not in the three-page paper. Agree the handoff calendar with the notified body instead of inventing a click-path.
Basic UDI-DI assignment itself is MDCG 2026-5, not this article.
What Fails If You Wait for a Repeal of Article 32, Treat a News Page as the Legal Text, or Count Certificate-Search Rows as Missing SSCPs?
| Trap | What people do | What the sources actually say |
|---|---|---|
| Wait for Article 32 repeal | Hold SOP changes until Parliament and Council amend the MDR | 2026-4 is a position paper. It does not repeal Article 32. The December 2025 simplification package (COM(2025) 1023 / SWD(2025) 1050) is a different instrument. |
| 26 May versus 28 May | Copy a 26 May 2026 mandatory-use date from a notified-body bulletin (LNE GMED's 2026-4 news page is one example) | Decision (EU) 2025/2371, the Commission overview, and MDCG 2026-4 all use 28 May 2026. |
| "The Commission amends the rules" | Treat consultancy headlines or commercial news summaries as the legal act | Cite MDCG 2026-4 plus Articles 29(4) and 32(1). Do not treat a news rewrite as the position paper. |
| Unvalidated clinical revision | Upload a PSUR-driven SSCP rewrite the notified body has not validated | 2019-9 still requires notified-body validation except for strictly editorial modifications. |
| Interim translation neglect | Assume the notified body still uploads FR/DE/IT files with the certificate | Footnote 1 and paragraph 3: interim notified-body upload is master only. |
| 27 February 2027 as certificate expiry | Treat the date as a CE-certificate cliff or as Regulation (EU) 2023/607 | Paragraph 4 is an SS(C)P upload "should / no later than" date for pre-mandate devices, three months before the 27 May 2027 notified-body certificate-upload end. |
| Certificate-search census | Treat 3,937 public certificate rows as missing SSCPs | That extract has no SSCP column. Absence of a column is not a headcount of missing files. |
1. Waiting for a statutory repeal
Some legal teams want a recast Article 32 before they change EUDAMED SOPs. 2026-4 will not give them that recast. If Production manufacturer-upload ships on the planned October 2026 timetable, waiting for a legislative amendment consumes the compressed window that paragraph 4 already flags. Keep the statutory upload sentence in the quality file, and operate the position-paper handover on top of it until 2019-9 is actually revised.
2. The 26 May 2026 date
LNE GMED's public 2026-4 note used 26 May 2026 as the mandatory-use date. The authentic date used by the Commission overview and by MDCG 2026-4 is 28 May 2026. Quote the Decision and the overview, not a secondary bulletin, in an audit response.
3. News pages as the legal text
Consultancy and commercial news pages restated 2026-4 within days. Some titled the change as a Commission amendment. The paper's page-1 disclaimer is the opposite. Keep MDCG 2026-4, the consolidated MDR/IVDR, and 2019-9 in the controlled source list. Use news pages only as a reminder that the PDF exists.
4. Uploading an unvalidated post-market revision
Once a manufacturer-upload button exists, it will be tempting to drop in the latest SSCP after the annual PSUR. If the PSUR changed clinical or performance content, 2019-9 still expects notified-body validation of that update. Do not confuse "we can now press upload" with "validation moved to the manufacturer."
5. Translations during the interim
If the device is marketed in France, Germany, and Italy, national language rules for the public summary still apply even while EUDAMED certificate registration does not take the translations. Hold those files under MDCG 2021-1 Rev.1 / MDCG 2022-12 and be ready to upload them when Production functionality exists. 2026-4 does not itself invent "product distribution holds"; it also does not excuse missing translations that Member State language rules already require.
Switzerland is a different publication model: under MedDO the manufacturer publishes the SSCP, and there is still no EUDAMED-style central SSCP platform. That contrast is in the Swissmedic 2026 PMS campaign guide. MDCG 2026-4 does not rewrite MedDO.
6. 27 February 2027 is not certificate expiry
Paragraph 4, in full on the operative lines:
"Therefore, manufacturers should upload SS(C)Ps in EUDAMED as soon as possible, and no later than 27 February 2027 for devices placed on the market before mandatory use considering that manufacturers and notified bodies should align on timelines to fulfil their registration obligations."
The verb is should, in a non-binding paper, scoped to devices placed on the market before mandatory UDI/Devices use. It is not a CE-certificate expiry, not a 2023/607 legacy-device cliff, and not a date that silently applies to every device first placed on the market after 28 May 2026. Those later devices are covered by the interim notified-body master upload and then by the manufacturer-upload rule once Production functionality exists.
The same paragraph explains why the two clocks are staggered. Notified bodies have a 12-month transition to upload corresponding certificates, ending 27 May 2027. When manufacturer-upload becomes available in Production, a significant number of registered devices may still lack a corresponding certificate and related SS(C)P in EUDAMED. The manufacturer file and the notified-body tick-box may therefore be weeks or months apart. Plan that gap; do not assume a single-day cut-over.
7. The public certificate-search schema is not an SSCP register
Analysts sometimes download the public EUDAMED certificate search and try to score "SSCP completeness."
A 25 July 2026 public certificate-search extract (stored in a 24 August 2026 snapshot of the official EUDAMED certificates search) contains 3,937 latest-version rows and 3,841 unique certificate numbers. The extract has 20 columns. None of them is an SSCP, SSP, summary, or document field. Certificate-type and applicable-legislation fields in that extract are unpopulated.
That is a schema limitation of the public certificate search, not a census of missing summaries, and not a finding that SSCPs are absent from EUDAMED. Do not scrape the live UDI/Device module to invent a substitute headcount. A different public-search stamp used in the July 2026 certificate-expiry analysis had 3,581 rows; that is an earlier snapshot, not an error in that article.
MDCG 2026-4 30/60/90-Day SKU Map: Playground Test, Production Handover, and the 27 February 2027 Backstop
This is an operational sequence for a manufacturer reading the paper in September 2026. It is not a timetable 2026-4 requires.
Days 1–30: Inventory and notified-body synchronization
- List every SKU that needs an SSCP (MDR Class III and implantables) or SSP (IVDR Class C and Class D). Map each family to its Basic UDI-DI and CE certificate.
- For certificates issued or updated after 28 May 2026, confirm whether the notified body has already deposited the master under the interim rule.
- Lock the QMS copy of that master against the version validated in conformity assessment. First-months EUDAMED operating work is in the post-go-live six-month plan; do not treat that plan as already covering 2026-4.
Days 31–60: Translation staging and Playground testing
- Stage translations for the Member States where the device is marketed, under MDCG 2021-1 Rev.1 and MDCG 2022-12. Language coverage follows those markets, not an automatic 24-language obligation.
- Use Playground, if the manufacturer-upload screens are actually there, to test SRN permissions, PDF constraints, and multi-file attachments. If they are not there yet, record that fact and keep the interim SOP.
- Agree with the notified body when certificate linkage and Basic UDI-DI ticks will happen for files you will upload later, including certificates not yet in EUDAMED.
Days 61–90: Production cut-over and pre-mandate filings
- When Production manufacturer-upload is confirmed live, upload masters and translations. Do not switch SOPs on the month label alone.
- Track notified-body ticks as certificate records appear. Keep timestamps in the technical file.
- For devices placed on the market before mandatory UDI/Devices use, work the paragraph 4 "as soon as possible, and no later than 27 February 2027" date against the notified body's 27 May 2027 certificate-upload work.
| Milestone | Source | Actor | Action |
|---|---|---|---|
| 27 November 2025 | Decision (EU) 2025/2371 (OJEU) | Commission | Notice declaring first four modules functional. |
| 28 May 2026 | Commission overview; MDCG 2026-4 §3 | Industry and notified bodies | Mandatory use of the first four modules. Interim SS(C)P rule begins. |
| July 2026 (planned) | MDCG 2026-4 footnote 2 | Manufacturers and notified bodies | Playground deployment for the new SS(C)P functions. |
| October 2026 (planned) | MDCG 2026-4 footnote 2 | Manufacturers | Production deployment. Manufacturer upload can begin only from this point, if the function is actually live. |
| 27 February 2027 | MDCG 2026-4 §4 | Manufacturers | Should upload SS(C)Ps no later than this date for devices placed on the market before mandatory use. |
| 27 May 2027 | MDCG 2026-4 §4 | Notified bodies | End of the 12-month transition to upload corresponding certificates. |
What Does This Cost: EUDAMED Has No SSCP User Fee Versus NB Validation, Translation, and Internal File Control?
Separate Commission/EUDAMED charges from notified-body conformity assessment, translation vendors, and internal labour. Do not present a single "EUDAMED transparency fee."
| Cost element | Who charges it | Source basis | What is known |
|---|---|---|---|
| EUDAMED actor, device, certificate, and SS(C)P file upload | European Commission | No statutory SSCP/SSP user tariff; the post-go-live guide already records that EUDAMED registration itself is free of charge | €0 Commission/EUDAMED fee for the upload |
| Notified-body validation of the SSCP/SSP | Notified body | MDR Article 50 / IVDR Article 46 require notified bodies to publish lists of standard fees for conformity assessment. Validation is part of that assessment, not a Commission invoice | Use the named notified body's published fee list. This page does not invent a euro band for SSCP review or for the tick-box |
| Translations and readability review | Language-service provider or internal staff | Commercial rates; 2019-9 puts translation correctness on the manufacturer's QMS | Manufacturer or provider cost, driven by target Member State languages |
| EUDAMED operations, version control, PRRC oversight | Internal RA/QA | Internal resource allocation | Manufacturer cost |
Any intermediary line-item labelled as an official EUDAMED document-upload tax is not a Commission fee. Notified-body tick-box work, if billed at all, sits on that body's published schedule — not on a Union SSCP tariff.
Frequently Asked Questions
Did MDCG 2026-4 repeal Article 32(1) so that notified bodies no longer upload anything?
No. MDCG 2026-4 did not repeal or amend MDR Article 32(1) or IVDR Article 29(1). Primary Union legislation is amended through the ordinary legislative procedure. 2026-4 is a non-binding position paper that assigns EUDAMED file management to the manufacturer under MDR Article 29(4) / IVDR Article 26(3) once the function exists. Until Production manufacturer-upload is available, notified bodies still upload the master with new certificates. After that, the notified body still validates the summary and indicates the validated file by ticking Basic UDI-DI boxes.
If our certificate was issued after 28 May 2026 and Production manufacturer-upload is not live yet, who uploads the master SSCP today?
The notified body uploads the master SSCP. Paragraph 3: until the new functionalities are fully available in Production, notified bodies need to upload SS(C)Ps alongside registration of new certificates, including updates. Confirm with your notified body that the master actually went in; do not assume the certificate row in the public search proves it.
Do we also upload the German and French translations, or does the notified body still do that?
Neither actor uploads those translations during the interim certificate-registration step. Footnote 1: certificate registration does not require SS(C)P translation upload. Manufacturers manage translations under MDCG 2021-1 Rev.1 and MDCG 2022-12. Once Production manufacturer-upload is live, the manufacturer uploads the required translations. That is a change from MDCG 2019-9, which still tells the notified body to upload translations within 15 days of receiving them.
Does the same handover apply to the IVDR Summary of Safety and Performance?
Yes. Paragraph 2: "This procedure will apply as well to SSP (IVDs)." For Class C and Class D, the manufacturer will upload the validated master SSP and translations under IVDR Article 26(3); the notified body indicates the validated file under IVDR Article 29(1) by the same Basic UDI-DI tick-box when the certificate is registered or linked.
Is 27 February 2027 a new certificate expiry date?
No. It is the paragraph 4 date by which manufacturers should upload SS(C)Ps for devices placed on the market before mandatory UDI/Devices use. It sits three months before the 27 May 2027 notified-body certificate-upload end. It does not expire CE certificates and does not amend Regulation (EU) 2023/607.
Is there a Commission or EUDAMED fee to upload an SSCP?
No. The Commission does not charge an SSCP/SSP user fee. Costs sit in notified-body conformity assessment (published under MDR Article 50 / IVDR Article 46), translation, and internal file control.
How Pure Global Supports EU MDR/IVDR and EUDAMED Compliance
Manufacturer-led EUDAMED document management still has to line up with notified-body validation and certificate linkage. Pure Global provides independent regulatory consulting for medical device and IVD manufacturers placing products on the Union market.
Regulatory teams can assist with:
- Structuring EU MDR consulting and EU IVDR consulting files, CERs, PERs, and SSCP/SSP drafts against MDCG 2019-9 / MDCG 2022-9, without treating MDCG 2026-4 as a new content template.
- Linguistic review of layperson sections for the Member States where the device is marketed.
- EUDAMED device-registration packages, SRN filings, and UDI data — separate from the SS(C)P file-upload actor question.
- Coordinating notified-body timelines for interim master upload, later manufacturer upload, and Basic UDI-DI ticks, including certificates not yet in EUDAMED.
- Portfolio gap work against the 27 February 2027 paragraph 4 date for pre-mandate devices.
To review an SSCP/SSP EUDAMED handover plan, contact Pure Global.
Disclaimer: Pure Global provides independent regulatory and compliance consulting. Pure Global is not a notified body, a competent authority, or the European Commission, and does not issue CE certificates.
Sources
- MDCG 2026-4 Position Paper: Management of SS(C)P in EUDAMED after mandatory use (PDF) — Medical Device Coordination Group (June 2026).
- Regulation (EU) 2017/745 on Medical Devices (MDR) consolidated text — Articles 29(4), 32, 50, 86, 103, and Annex VI Part A Section 2.
- Regulation (EU) 2017/746 on In Vitro Diagnostic Medical Devices (IVDR) — Articles 26(3), 29, and 46.
- MDCG 2019-9 Rev.1 Summary of safety and clinical performance (PDF) — Medical Device Coordination Group (March 2022).
- Commission Decision (EU) 2025/2371 — notice on EUDAMED functionality, OJEU 27 November 2025.
- European Commission EUDAMED overview — mandatory use of the first four modules as of 28 May 2026.
- EUDAMED Information Centre: SS(C)P Management — still nested under notified-body actor topics as of 5 September 2026.
- MDCG 2021-1 Rev.1 Guidance on harmonised administrative practices until EUDAMED is fully functional (MDR) (PDF) — Medical Device Coordination Group (May 2021).
- MDCG 2022-12 Harmonised administrative practices until Eudamed is fully functional (IVDR) — Medical Device Coordination Group (July 2022).
- MDCG 2022-9 Rev.1 Summary of safety and performance template for IVDs — Medical Device Coordination Group (April 2024).
- MDCG endorsed documents and other guidance index — lists MDCG 2026-4 (June 2026) and still lists 2019-9 Rev.1 without a 2026 revision number.