EUDAMED: Module-by-Module Status, What Is Mandatory Now, and the SRN Registration Sequence

EUDAMED is not one system with one go-live date. It is six modules that have been switched on separately over more than five years, and at any given moment some are legally mandatory, some are open for voluntary use, and some do not exist yet. A page that tells you “EUDAMED is mandatory” or “EUDAMED is delayed” is almost certainly describing a status that has since changed.

Status on this page was verified against European Commission sources on 26 August 2026. Every module row below carries its own legal basis and its own date. Where a deadline is proposed rather than in force, this page says so explicitly rather than presenting it as settled.

Module-by-module status, verified 26 August 2026

Module	Status	Voluntary use opened	Who enters data
Actor registration (ACT)	Mandatory since 28 May 2026	December 2020	Manufacturers, authorised representatives, importers, system/procedure pack producers
UDI/Device registration (UDI/DEV)	Mandatory since 28 May 2026	October 2021	Manufacturers and SPP producers
Notified Bodies and Certificates (NB/CRF)	Mandatory since 28 May 2026	October 2021 (excluding the scrutiny and CECP functionalities)	Notified bodies and designating authorities
Market Surveillance (MSU)	Mandatory since 28 May 2026 — for competent authorities and the Commission only	Never opened for voluntary use	Competent authorities only; notified bodies have view access where applicable
Post-market surveillance and Vigilance (VGL)	Not available. In development. No mandatory date in force	Will not open for voluntary use at all	Manufacturers, authorised representatives, competent authorities, notified bodies
Clinical Investigations and Performance Studies (CI/PS)	Not available. Under analysis. No mandatory date in force	Will not open for voluntary use at all	Sponsors, competent authorities

The first four became mandatory together, on the same trigger. The last two are on a different track and are the part of this page most likely to be out of date first — see what is still moving.

Why the dates move: Article 34 MDR and the gradual roll-out

EUDAMED is established by Article 33 of Regulation (EU) 2017/745 (MDR) and the corresponding provisions of Regulation (EU) 2017/746 (IVDR). Its detailed arrangements sit in Commission Implementing Regulation (EU) 2021/2078 of 26 November 2021.

The mechanism that actually determines when you have to use it was rewritten by Regulation (EU) 2024/1860 of 13 June 2024, in force from 9 July 2024. Before that amendment, the whole of EUDAMED had to be declared functional as a single unit — meaning the last module finished would have gated all six. Article 34 MDR as amended allows the Commission to audit modules individually or in groups, and to switch them on as they are finished.

The sequence for any module is fixed and worth memorising, because it is the only thing that converts a roadmap into a legal obligation:

1. An independent audit verifies the module against the functional specifications drawn up by the MDCG and the Commission.
2. The Commission verifies the result and informs and consults the MDCG.
3. The Commission publishes a notice in the Official Journal confirming the module’s functionality.
4. The related obligations become applicable six months after that publication — Article 123(3)(d) MDR and Article 113(3)(e) IVDR.

The operative test is therefore simple: has a notice been published in the OJEU for that module? If not, no date announced for it is binding, however confidently it is quoted. A roadmap quarter is a plan; an OJEU notice starts a six-month clock.

Until a module’s obligations bite, the corresponding provisions of the old Directives — 93/42/EEC (MDD), 90/385/EEC (AIMDD) and 98/79/EC (IVDD) — and their national transposition measures continue to apply to registration, certificate notification, vigilance and clinical investigations. That is deliberate: it creates a clean cut-off and avoids double registration. Note that Regulation (EU) 2024/1860 also deleted Article 120(8) MDR and Article 110(8) IVDR, which had previously allowed voluntary EUDAMED registration to substitute for national registration during the transition. It no longer does.

The 27 November 2025 notice and the three dates it set

Commission Decision (EU) 2025/2371 of 26 November 2025, published in the Official Journal on 27 November 2025, declared the functionality of the first four modules. That single publication set three separate deadlines:

Date	What it is	Applies to
28 May 2026	Mandatory use begins (notice + 6 months)	ACT, UDI/DEV, NB/CRF, MSU
28 November 2026	Deadline to register the existing device backlog (notice + 12 months)	Legacy and Regulation devices already on the market before 28 May 2026 whose additional units continue to be placed on the market
28 May 2027	Deadline to register the existing certificate backlog (notice + 18 months)	MDR/IVDR certificates issued before 28 May 2026, for Regulation devices that are or must be registered in UDI/DEV

The two later dates are the ones most often missed. Becoming compliant on 28 May 2026 for new products does not discharge the backlog obligations — those run on their own clocks, and as of this page’s verification date the November 2026 device-backlog deadline is roughly three months away.

Actor registration and the SRN: the gate everything else sits behind

Nothing else in EUDAMED works until this step is done. The Actor module is not merely the first item on a checklist — it is a technical prerequisite: an organisation cannot register a device, register a certificate against its name, or file a vigilance report without an actor record.

SRN versus Actor ID

Two identifiers exist, they share a structure, and they are not the same thing:

• Single Registration Number (SRN) — assigned to economic operators within the scope of Article 31 MDR / Article 28 IVDR: manufacturers, authorised representatives and importers. An SRN must be held before a device is placed on the market.
• Actor ID — same structure, assigned to registered actors outside Article 31 / Article 28 who still need to act in EUDAMED.

Actors who need an Actor ID rather than an SRN include:

• System and procedure pack producers (SPPPs), before placing the system or pack on the market.
• Manufacturers who place only custom-made devices on the market, so they can use other modules — for example to report a serious incident concerning a custom-made device.
• Manufacturers of class III custom-made implantable devices only, so a notified body can register the QMS certificate issued under the second subparagraph of Article 52(8) MDR.
• Sponsors of clinical investigations and performance studies, to use the CI/PS module. Sponsor registration is not yet possible — it opens only when CI/PS becomes mandatory.

Who does not register

Distributors are not required to register in EUDAMED. They may still face registration requirements at national level in the Member States where they make devices available — that obligation has not been absorbed by EUDAMED and should be checked country by country.

Manufacturers, authorised representatives, importers and SPPPs who stopped placing devices on the market before 28 May 2026 and place none after it do not need to register as actors — unless a post-market surveillance or vigilance action becomes necessary, in which case they must register after all. Exiting a product line does not permanently exit you from EUDAMED; a serious incident years later pulls you back in.

UDI/Device registration: what “the device” means here

The single most common misreading of this module is the unit of registration. In the MDR and IVDR the word “device” almost always means an individual sales unit. In the UDI/DEV module it does not. Registration happens at the level of the device identifier, excluding production identifiers — the UDI-DI for Regulation devices and systems/procedure packs, and the EUDAMED ID or UDI-DI for legacy devices.

So there is one registration per UDI-DI, covering every individual unit sharing that identifier, whatever their lot numbers, serial numbers or manufacturing dates (the UDI-PI). This is the EU registration counterpart to the identifier structure described on our FDA unique device identifier and GUDID guide — the identifier grammar is broadly familiar, but the database, the legal basis and the submission obligations are entirely separate.

The two timing rules

First unit placed on the market on or after 28 May 2026: the device registration must be complete before that first unit is placed on the EU market. Registration is a precondition of market placement, not a follow-up task.

First unit placed on the market before 28 May 2026, with further units placed after it: registration must be complete by 28 November 2026 — twelve months from the OJEU notice. This is the backlog rule, and it covers both legacy devices and Regulation devices.

What cannot or need not be registered

• Custom-made devices, investigational devices and devices for performance studies are not registered in UDI/DEV.
• “Old” devices, as described in MDCG 2021-25 Rev. 1 and MDCG 2022-8, cannot be registered in UDI/DEV at all.
• Devices no longer placed on the market as of 28 May 2026 need not be registered — unless a PMS or vigilance action occurs, at which point the device must be registered so the report can reference it.
• A legacy device need not be registered if “the same device” is already registered as a Regulation device — meaning shared identification such as UDI-DI, catalogue or reference number, or trade name following from shared characteristics. A change that would trigger assignment of a new UDI-DI means it is not the same device.

For custom-made and “old” devices that cannot be registered, the manufacturer supplies a limited device data set inside the vigilance report itself when a serious incident report or field safety corrective action arises. That route depends on the vigilance module, which does not yet exist — see below.

One publication nuance worth planning for: submitting the full device data set discharges the Article 29 MDR / Article 26 IVDR obligation, but for certain devices the UDI and device data only become publicly visible once the notified body has entered the corresponding certificate information in the NB/CRF module. Your registration can be complete and compliant while still invisible on the public site, because the dependency runs through a different actor.

Notified Bodies and Certificates

Any certificate issued after 28 May 2026 must be registered in the NB/CRF module. Updates and decisions issued after that date that relate to certificates issued before it must also be registered. The backlog of MDR/IVDR certificates issued before mandatory use must be registered by 28 May 2027 — but only for Regulation devices that are or must be registered in UDI/DEV, and only the latest certificate version plus, where applicable, the latest notified-body decision on that version.

The provisions this module carries for notified bodies are Article 53(2) MDR / 49(2) IVDR (exchange on withdrawn and refused applications), Article 54(3) MDR (the clinical evaluation consultation procedure), Article 55(1) MDR / 50(1) IVDR (the mechanism for scrutiny), and Article 56(5) MDR / 51(5) IVDR (certificates issued, amended, suspended, reinstated, withdrawn, refused, or restricted). For designating authorities it carries the second subparagraph of Article 44(12) MDR / 40(12) IVDR and Article 46(7)(d)–(e) MDR / 42(7)(d)–(e) IVDR.

The CECP and scrutiny functionalities were excluded from the voluntary period, which creates a specific back-fill problem. Certificates registered voluntarily before 28 May 2026 could not carry them. After mandatory use, there is a way to indicate that the CECP — and possibly the mechanism for scrutiny — was carried out outside EUDAMED. But if the notified body did not notify under the mechanism for scrutiny outside EUDAMED before mandatory use, it must do so in EUDAMED when registering the certificate, even where the CECP itself was recorded as having happened outside the system.

Separately, the obligation on notified bodies to upload the summary of safety and clinical performance under Article 32(1) MDR / Article 29(1) IVDR applies from the moment the related certificate is registered in EUDAMED — it is triggered by certificate registration, not by a calendar date.

What is being registered here is the output of conformity assessment against a quality management system built to ISO 13485, with risk management under ISO 14971 and, for software, a lifecycle under IEC 62304. EUDAMED records the certificate; those standards are what earns it.

Market Surveillance: mandatory, but not yours

The MSU module became mandatory on 28 May 2026 alongside the other three, which is why it appears in every “four modules are live” summary. It imposes no obligation on manufacturers. Access is restricted to competent authorities and, for viewing where applicable, notified bodies; the data in it is managed only by competent authorities. It never had a voluntary phase. If you are a manufacturer building a EUDAMED readiness plan, this row is informational only.

Vigilance and post-market surveillance: not in force, and not voluntary either

The VGL module is in development and not available. There is no OJEU notice for it, so no mandatory date is in force. It will also have no voluntary period: unlike the actor, device and certificate modules, it will be released at the moment it becomes mandatory and must be used from that moment.

Proposed, not in force: the Commission’s EUDAMED modules timeline published in November 2025 indicated publication of the functionality notice for the vigilance module in Q4 2026, giving mandatory use in Q2 2027 after the six-month transition. That document carries an explicit caveat that the vigilance timeline may be updated depending on the audit results. As of 26 August 2026 the Commission’s EUDAMED overview still lists the module as “in development”, and no notice had been published. Treat Q2 2027 as a planning assumption to re-check, not a deadline to certify against.

Until it lands, vigilance reporting continues through national processes as described in MDCG 2021-1 Rev. 1 and MDCG 2022-12. Serious incident reports, field safety corrective actions, field safety notices, trend reports, periodic summary reports and PSURs do not go into EUDAMED yet. Our guide to field safety corrective actions covers the Article 87 notification clocks, the Article 89(8) field safety notice requirements and the cross-walk to the US regimes — that is the substance of what will eventually be filed here; this module is only the destination.

Two mechanics are worth setting up for now, because they arrive on day one:

• Open reports migrate mid-flight. For a vigilance report initiated under national process and still open when VGL becomes mandatory, subsequent actions must be done in EUDAMED. There is no retrospective registration of the earlier versions — only actions occurring from the mandatory date onward. EUDAMED will temporarily accept a first submission that is not an “initial” version (a follow-up or final report), so that ongoing cases can be carried across.
• A vigilance event can force a device registration. A device withdrawn from the market before 28 May 2026, and therefore exempt from UDI/DEV registration, must be registered if a PMS or vigilance action later arises — and the manufacturer, plus the authorised representative where applicable, must be registered as actors first. Where the action concerns a legacy device and not “the same” Regulation device, that legacy device must exceptionally be registered in UDI/DEV so the report can reference it.

The provisions the module will carry are Article 86(2) MDR / 81(2) IVDR (PSURs), Article 87 MDR / 82 IVDR (serious incidents, periodic summary reports, FSCAs and field safety notices), Article 88 MDR / 83 IVDR (trend reporting), and Article 89(5), (7), (9) and the third subparagraph of 89(8) MDR / Article 84 IVDR equivalents (analysis and inter-authority exchange, coordinated assessment, FSN publication). Article 90 MDR / 85 IVDR — analysis of vigilance data — is explicitly slated for implementation after the first mandatory version of the module ships.

Clinical investigations and performance studies: under analysis, no date

The CI/PS module is under analysis. No OJEU notice, no quarter proposed for one in the published timeline, and no voluntary phase — it too will be released at the point it becomes mandatory. When the notice is published, obligations relating to both the CI/PS module and sponsor registration in the actor module become applicable six months later.

The coordinated assessment procedure under Article 78(14) MDR / Article 74(14) IVDR has a two-stage clock of its own:

• Six months after the CI/PS notice — available for Member States that have agreed to apply it. A voluntary phase.
• Five years after the CI/PS notice — mandatory for all Member States where a sponsor submits a single application.

Before the module exists, Member States and sponsors may agree alternative arrangements for coordinated assessment, per MDCG guidance. Device clinical investigations themselves continue to run to ISO 14155; performance studies for IVDs are covered under IVD clinical trials. Note that this is a different system from CTIS, which handles medicinal-product trials under the Clinical Trials Regulation — devices do not go there.

The registration sequence, in dependency order

EUDAMED enforces an order. Attempting these steps out of sequence produces blocked submissions rather than helpful errors.

1. Register the actor and obtain the SRN or Actor ID. Manufacturer, authorised representative and importer each register separately and each hold their own SRN — one organisation’s registration does not cover its supply-chain partners. For a non-EU manufacturer the authorised representative’s registration is verified as part of the process, so start it early.
2. Confirm which of your devices are in scope. Exclude custom-made, investigational and performance-study devices. Identify “old” devices, which cannot be registered. Determine, per UDI-DI, whether a legacy device is already covered by “the same” registered Regulation device.
3. Split the remaining devices into two queues by first market placement. Anything whose first unit goes to market from 28 May 2026 onward must be registered before that placement. Everything already on the market and continuing must be registered by 28 November 2026.
4. Register at UDI-DI level, not unit level, and expect uniqueness checks at submission.
5. Confirm your notified body has registered the certificate. This is not your submission, but for certain devices your data stays invisible on the public site until it happens, and the certificate backlog runs to 28 May 2027.
6. Keep vigilance on national processes until the VGL module is declared functional, while making sure every entity that might need to file — including for discontinued product lines — already holds an actor registration.
7. Do not plan sponsor registration yet. It is not available until CI/PS becomes mandatory.

What is still moving, and how to re-check it

This is a live regulatory target. The following are the specific things that change, and the authoritative place to check each:

• Whether an OJEU notice has been published for VGL or CI/PS. This is the only fact that converts a proposed quarter into a legal deadline. Check the Commission’s EUDAMED overview page and the Official Journal, not secondary summaries.
• The vigilance timeline itself — expressly conditional on audit results in the Commission’s own roadmap.
• MDCG guidance revision numbers. MDCG 2021-13 Rev. 1 on actor registration is flagged for update; MDCG 2022-8 on legacy devices likewise.
• Form versions, including the manufacturer incident report form, which are revised independently of the regulation.

Two sourcing caveats, stated plainly. First, MDCG guidance is not legally binding — it represents the view of the Medical Device Coordination Group and is intended to assist uniform application, but it does not alter the Regulations and is without prejudice to interpretation by the Court of Justice or national courts. The Commission’s own gradual roll-out Q&A carries a similar disclaimer: it has not been formally endorsed by the Commission and is described as neither necessarily comprehensive nor complete. Second, the consolidated text of Regulation (EU) 2017/745 on EUR-Lex was not retrievable from the environment used to verify this page on 26 August 2026; the article numbers, provisions and dates above were taken from European Commission publications on health.ec.europa.eu and from the Commission’s own Q&A and timeline documents rather than from the consolidated legal text. Where a decision turns on exact statutory wording, read the Regulation itself on EUR-Lex.

Frequently asked questions

Is EUDAMED registration mandatory now?

Partly. Four of the six modules — actor registration, UDI/device registration, notified bodies and certificates, and market surveillance — became mandatory on 28 May 2026. The vigilance and post-market surveillance module and the clinical investigations and performance studies module are not yet available and carry no binding date. Verified 26 August 2026.

What is an SRN and who needs one?

The Single Registration Number is the identifier EUDAMED assigns to economic operators within the scope of Article 31 MDR / Article 28 IVDR — manufacturers, authorised representatives and importers — and it must be held before a device is placed on the market. Other actors who need to act in EUDAMED, such as system and procedure pack producers, custom-made-device-only manufacturers and clinical investigation sponsors, receive an Actor ID with the same structure instead.

Do distributors have to register in EUDAMED?

No. Distributors are outside the EUDAMED registration requirement. They may still be required to register at national level in the Member States where they make devices available.

When must devices already on the market be registered?

By 28 November 2026 — twelve months from the 27 November 2025 OJEU notice — for legacy or Regulation devices whose first unit was placed on the market before 28 May 2026 and whose additional units continue to be placed on the market after it. Devices no longer supplied need not be registered unless a post-market surveillance or vigilance action arises.

Can I file vigilance reports in EUDAMED yet?

No. The vigilance and post-market surveillance module is in development, is not open for voluntary use, and has no OJEU notice. Serious incident reports, FSCAs, field safety notices, trend reports and PSURs continue through national processes under MDCG 2021-1 Rev. 1 and MDCG 2022-12 until it becomes mandatory.

Is the EU UDI the same as the FDA UDI?

The identifier structure is broadly comparable — a device identifier plus production identifiers, issued by accredited issuing agencies — but the databases and legal obligations are separate. EU device data goes to the EUDAMED UDI/DEV module under Article 29 MDR / Article 26 IVDR; US data goes to GUDID under 21 CFR Part 830. Registration in one does nothing for the other.

What happens if a module’s timeline slips?

Nothing binding changes until an OJEU notice is published, because the six-month clock in Article 123(3)(d) MDR runs from that publication and nothing else. Until then the corresponding Directive provisions and their national transpositions continue to apply.

Primary sources

• European Commission — EUDAMED overview and state of play (module status, verified 26 August 2026)
• Commission Decision (EU) 2025/2371 of 26 November 2025 — notice on the functionality of certain EUDAMED electronic systems, OJEU 27 November 2025
• Regulation (EU) 2024/1860 of 13 June 2024 — gradual roll-out of EUDAMED, supply interruption notification, IVD transitional provisions; in force 9 July 2024
• Commission Implementing Regulation (EU) 2021/2078 of 26 November 2021 — detailed arrangements for EUDAMED
• Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746 (IVDR)
• Commission Q&A on the gradual roll-out of EUDAMED (non-binding, not formally endorsed)
• EUDAMED modules timeline, November 2025 (proposed dates for VGL and CI/PS)
• MDCG 2021-13 Rev. 1 (actor registration), MDCG 2021-25 Rev. 1 and MDCG 2022-8 (legacy and “old” devices), MDCG 2021-1 Rev. 1 and MDCG 2022-12 (vigilance in the absence of EUDAMED) — all non-binding

Related CASRAI resources

• Field safety corrective action: FSCA vs recall vs field safety notice — the Article 87 clocks and the EU/US cross-walk for what will eventually be filed in the vigilance module
• UDI medical device: FDA unique device identifier requirements — the US identifier and GUDID side of device registration
• ISO 13485: medical device quality management systems — the QMS behind the certificates registered in NB/CRF
• ISO 14971: the risk management file and benefit-risk determination
• IEC 62304: software safety classes and lifecycle deliverables
• 21 CFR Part 820 and the QMSR transition — the US quality-system counterpart
• Software as a medical device: classification and regulatory pathways
• FDA medical device regulations: classification, 510(k) and PMA
• Laboratory compliance pillar