---
title: EUDAMED Status in 2026: What Modules Are Live and What Still Is Not
description: EUDAMED module status in early 2026: what is live, what is voluntary, and how the Article 34 mechanism determines when mandatory use kicks in.
authors: Tibor Zechmeister, Felix Lenhard
category: EUDAMED, UDI & Registration
primary_keyword: EUDAMED status 2026
canonical_url: https://zechmeister-solutions.com/en/blog/eudamed-status-2026
source: zechmeister-solutions.com
license: All rights reserved. Content may be cited with attribution and a link to the canonical URL.
---

# EUDAMED Status in 2026: What Modules Are Live and What Still Is Not

*By Tibor Zechmeister (EU MDR Expert, Notified Body Lead Auditor) and Felix Lenhard.*

> **As of early 2026, EUDAMED is operating as a partially functional system under the staged rollout mechanism of MDR Article 34. Some of the six modules. Actor registration, UDI/device registration, certificates and Notified Bodies. Have been available to economic operators on a voluntary basis; others are at earlier stages of implementation. Mandatory use of any individual module is triggered only after the European Commission formally declares that module functional and publishes a notice in the Official Journal, followed by the transitional period set out in Article 34 and the related provisions of Regulation (EU) 2017/745. Until a given module is declared mandatory, the pre-existing national registration, vigilance and reporting obligations remain in force in parallel. This post is a snapshot in time. Before acting on any specific module, read the current Commission communications on the EUDAMED information page, because the live status of any individual module can change between audits and declarations.**

**By Tibor Zechmeister and Felix Lenhard. Last updated 10 April 2026.**

---

## TL;DR

- EUDAMED is the European Database on Medical Devices set up under MDR Article 33. It is structured as six modules: actor registration, UDI/device registration, Notified Bodies and certificates, clinical investigations and performance studies, vigilance and post-market surveillance, and market surveillance.
- MDR Article 34 is the legal switch that turns a module from voluntary to mandatory. The Commission must declare the module functional and publish a notice, after which the transitional period runs before enforcement.
- As of the date on this post, the early modules (actor registration, UDI/device registration, certificates) have been available for voluntary use by economic operators for an extended period. Later modules are at earlier stages.
- This post deliberately does not publish specific 2026 go-live dates by module. Those dates depend on Commission implementing decisions that are published as each module is audited and are best read from the source on the day you need them.
- Whatever the current mandatory status, the underlying MDR obligations (registration of actors under Article 31, registration of devices under Article 29, SSCP publication under Article 32, vigilance reporting under Articles 87-92) apply. The only question EUDAMED status changes is the channel through which you discharge them.

---

## Why a status post has to be read as a snapshot

A founder reading about EUDAMED will find sources from different years contradicting each other. A blog from 2022 says the system is "not yet functional." A guidance note from 2024 says certain modules are "voluntarily available." A 2025 LinkedIn post announces that a module has been "declared functional." All of those statements were true when written and not all of them are true now. This is the nature of a system that is being rolled out module by module under an Article 34 mechanism that was itself amended to allow staged functional declarations rather than a single all-or-nothing switch.

The only way to read EUDAMED status accurately is to treat every status claim. Including this one. As time-stamped. What you need is not a dated list of go-live dates memorised from a blog. What you need is the mechanism, so that when you open the Commission's EUDAMED information page on the morning you actually have to act, you can read the live status yourself and know what it means. That is what this post is for.

## How Article 34 determines module status

MDR Article 34 governs the functioning of EUDAMED and, critically, the conditions under which mandatory use is triggered. The mechanism has two parts.

First, the technical precondition. The Commission, in collaboration with the Medical Device Coordination Group, must be satisfied that EUDAMED. Or, under the amended mechanism, an individual module of EUDAMED. Has reached full functionality and meets the functional specifications. An independent audit is conducted to confirm this.

Second, the legal trigger. Once functionality is confirmed, the Commission publishes a notice to that effect in the Official Journal of the European Union. Mandatory use of the relevant provisions of the MDR that rely on EUDAMED then becomes enforceable after the transitional period that Article 34 and the related transitional provisions prescribe.

Article 34 was amended so that the Commission can make this declaration on a module-by-module basis. Under this staged approach, a module that has passed its audit can be declared functional and made mandatory independently of other modules that are still maturing. The practical effect is that at any given moment EUDAMED can contain a mixture of mandatory modules, voluntary modules, and modules still under development. That is precisely the situation in 2026.

Until the Commission publishes the functional declaration for a given module and the transitional period expires, the legal obligations that the MDR places on economic operators for that area continue to be discharged through the pre-existing national channels. EUDAMED voluntary use does not replace those national obligations. It runs in parallel with them.

## The six modules and how to read their status

The six modules defined around MDR Articles 29-33 and operationalised in Commission Implementing Regulation (EU) 2021/2078 each have their own rollout trajectory. Here is what each one is, what it touches in the Regulation, and how to read its status.

**1. Actor registration.** This module registers manufacturers, authorised representatives, importers, and system/procedure pack producers, and issues each one a Single Registration Number (SRN). It is the entry point into EUDAMED and the foundation for everything else, because every subsequent module action is tied to an SRN. The underlying obligation is MDR Article 31, with data specified in Annex VI Part A. This module has been available to economic operators for voluntary use for the longest. To check its current mandatory status, read the Commission notice on the EUDAMED information page.

**2. UDI and device registration.** This module registers devices themselves and their Unique Device Identifiers. The underlying obligations are in MDR Articles 27, 28 and 29, with the data specification in Annex VI Parts B and C (Part C covering the UDI data elements). Manufacturers submit the Basic UDI-DI and the associated device data under their SRN. This module has likewise been available for voluntary use for an extended period. Its mandatory status is declared separately from actor registration.

**3. Notified Bodies and certificates.** This module holds the list of designated Notified Bodies and the certificates they issue, restrict, suspend or withdraw under MDR. It is the channel through which your Notified Body's regulatory decisions about your device become visible in the central database. When operational, it is the module that turns a certificate into a public record.

**4. Clinical investigations and performance studies.** This module holds information on clinical investigations under MDR Articles 62-82 and Annex XV, including sponsor applications, summaries and results. It is how the transparency purpose of Article 33(2) is delivered for clinical investigations. Its implementation schedule has been later than the first three modules.

**5. Vigilance and post-market surveillance.** This module handles serious incident reports, field safety corrective actions, trend reports, and Periodic Safety Update Reports under MDR Articles 87-92 and 83-86. Until it is declared mandatory, vigilance reporting continues to flow through the established national Competent Authority channels. This module is particularly consequential for manufacturers with devices already on the market, because the reporting cadence does not stop while the module transitions.

**6. Market surveillance.** This module supports the activities of Competent Authorities under MDR Articles 93-100. Inspections, non-compliance findings, enforcement actions, and coordination between Member States. It is primarily an authority-facing module; manufacturers interact with it indirectly, through the actions authorities take.

For each of the six modules, the question "is this module mandatory today?" is answered by the Commission's most recent notices, not by any blog post. The question "what is the underlying MDR obligation that this module serves?" is answered by the articles listed above, and those articles do not change when the module does.

## The difference between voluntary and mandatory use

This is the point that founders most often misread. A module being available for voluntary use is not the same as a module being mandatory. The difference matters for compliance.

Voluntary use means the Commission has opened the technical system so that economic operators can enter data into the relevant module. Entering data is permitted and often sensible, because it puts your information into the database, familiarises your team with the workflows and data structures, and creates an audit trail that later aligns cleanly with the mandatory phase. But voluntary use does not satisfy the parallel national obligations that still apply under the transitional arrangement.

Mandatory use means the Commission has formally declared the module functional, published the notice, the transitional period has run its course, and the MDR provisions that depend on EUDAMED are now enforceable through EUDAMED as the legal channel. At that point, the national registration or reporting obligation for that specific area is superseded by the EUDAMED obligation.

The practical implication: if you register your company in EUDAMED actor registration while that module is still voluntary, you have not discharged your obligations under any national actor registration scheme that applies to you. You have simply filed the data in two places instead of one. If your national authority still requires a notification, you still have to make it. The additive situation ends only when the Commission flips the switch for that specific module.

## What startups must do regardless of mandatory status

The underlying obligations do not wait for EUDAMED. Whatever the status of any individual module, a startup placing a device on the EU market under MDR must do the following.

Register as an economic operator. The obligation for manufacturers, authorised representatives and importers to register is in MDR Article 31. If the EUDAMED actor registration module is not yet mandatory in your case, discharge the equivalent national obligation in the Member State where you are established. If it is mandatory, discharge it through EUDAMED. Either way, you must be registered before placing a device on the market.

Assign and manage UDIs. The UDI obligation is in Article 27. Regardless of whether the device registration module of EUDAMED is mandatory yet, your device must carry a UDI and your labelling and packaging must be compliant. Building UDI assignment into the product development process is far cheaper than retrofitting it onto an existing product family.

Keep your data clean and consistent. Whatever is currently in any national database about you, and whatever you have entered into EUDAMED voluntarily, must be consistent with your technical documentation, your Notified Body submission, your labels and your IFU. When a module moves from voluntary to mandatory, inconsistency becomes a finding.

Report vigilance events on time. Articles 87-92 set reporting deadlines for serious incidents and field safety corrective actions. Those deadlines run from the moment the manufacturer becomes aware of the event and do not pause while EUDAMED modules transition. Until the vigilance module is mandatory, report through the established national channels.

Publish the SSCP for implantable and Class III devices. Article 32 requires the Summary of Safety and Clinical Performance for implantable and Class III devices (other than custom-made or investigational). The SSCP is ultimately made public through EUDAMED. Prepare it as part of the technical documentation regardless of which module is currently live, because the document is a deliverable of the conformity assessment and is validated by the Notified Body.

## How to check current status before publication or action

There is one reliable method and it takes five minutes. Open the European Commission's EUDAMED information page. Look for the most recent Commission communications and notices. The page lists which modules are available for voluntary use, which have been declared functional, and the date of the corresponding notice in the Official Journal. If your compliance action depends on whether a module is mandatory, note the Official Journal reference and keep it in your quality records.

If you are unsure how to interpret a declaration or a transitional period, ask your Notified Body. Notified Bodies are required to follow EUDAMED status closely and are the most consistent source of interpretation for the manufacturers they assess. If you do not yet have a Notified Body and the question is blocking your planning, this is one of the areas where a consultant who reads the Commission page weekly will save you hours per decision. But the information itself is public and free.

For the rhythm of what is changing across the MDR landscape more broadly, see [MDR regulatory updates 2026](/blog/mdr-regulatory-updates-2026). EUDAMED module declarations are one of the items that a maintained regulatory calendar picks up.

## The Subtract to Ship angle on EUDAMED status

There is a temptation, when facing a moving target like EUDAMED, to add work. To build a "EUDAMED readiness programme." To appoint a "EUDAMED champion." To run a "EUDAMED gap analysis" as a separate engagement. Most of that is noise.

The Subtract to Ship discipline says the opposite. Strip the EUDAMED workstream down to what MDR Articles 29, 30, 31, 32, 33 and 34 actually require. That is one SRN. One clean set of Annex VI Part A data. One set of UDI assignments consistent with Articles 27-29 and Annex VI Part C. One SSCP per Article 32 device. One vigilance process wired to Articles 87-92 and routed through whichever channel is currently mandatory. One change-management hook that triggers a EUDAMED update when any of that information changes. Everything else is overhead.

The status of individual modules changes which channel you file through. It does not change which information you have to have ready. When the Commission flips a module to mandatory, a startup that has already built the underlying data cleanly finds the transition is an afternoon of filing. A startup that used "we'll wait until it's mandatory" as an excuse not to prepare finds the transition is a quarter of work done under deadline pressure.

See [the Subtract to Ship framework for MDR](/blog/subtract-to-ship-framework-mdr) for the full methodology.

## Reality Check. Where do you stand on EUDAMED status?

1. Do you know, on the day you are reading this, which EUDAMED modules are currently mandatory and which are voluntary, or are you relying on a memory from a source that may be months old?
2. Have you bookmarked the Commission's EUDAMED information page and assigned a team member to check it on a fixed cadence (monthly at minimum)?
3. For each pre-existing national registration or reporting obligation you currently comply with, can you name the MDR article behind it and the module that will eventually absorb it?
4. If a module transitioned from voluntary to mandatory tomorrow, do you have the underlying data already prepared (SRN, Basic UDI-DIs, Annex VI data, SSCP for Article 32 devices, vigilance workflow) so that transition is a filing exercise rather than a build?
5. Is your quality system set up to record the Official Journal reference for each Commission functional declaration that affects you, so that your records show exactly when each module became mandatory in your case?
6. If your Notified Body asked you in a surveillance audit how you track EUDAMED status, do you have a written procedure to show them?

If you cannot answer four or more of these cleanly, your EUDAMED posture is reactive, and reactive is expensive in a moving-target environment.

## Frequently Asked Questions

**What is the current status of EUDAMED in 2026?**
As of early 2026, EUDAMED is operating under the staged rollout mechanism of MDR Article 34, with some modules available for voluntary use and mandatory status declared module by module through Commission notices. Because module status changes as new functional declarations are published, the authoritative source is the European Commission's EUDAMED information page on the day you need to act.

**Which EUDAMED modules are live right now?**
The early modules. Actor registration, UDI/device registration, and Notified Bodies and certificates. Have been open to economic operators on a voluntary basis for an extended period. Later modules follow on their own schedules. The specific mandatory status of each module at any given moment is set by Commission notices and should be read from the source.

**What does "voluntary" versus "mandatory" mean for EUDAMED?**
Voluntary means the module is technically available and you are permitted to file data into it, but the underlying MDR obligation still has to be discharged through any parallel national channel that applies. Mandatory means the Commission has declared the module functional under Article 34, published the notice, the transitional period has run, and EUDAMED is the legal channel for that obligation.

**Can I rely on a blog post for EUDAMED module go-live dates?**
No, and you should be sceptical of any blog post that publishes specific 2026 module go-live dates as if they were fixed. Module functional declarations are made by Commission implementing decisions and can shift. The Commission's EUDAMED information page and the Official Journal are the only sources you should act on.

**Does Article 34 still allow module-by-module rollout?**
Yes. Article 34 has been amended to allow the Commission to declare individual modules functional independently, so that a module can become mandatory ahead of others. This is the mechanism under which EUDAMED has been rolling out.

**What happens if I wait until a module becomes mandatory before doing any EUDAMED work?**
You can, technically, but it compresses the work into the transitional window and raises the cost of any errors. The better approach is to prepare the underlying data. SRN readiness, UDI assignments, Annex VI data, SSCP content. Independently of module status, so that when a module becomes mandatory the transition is a filing exercise.

## Related reading

- [What is EUDAMED? The European database on medical devices explained](/blog/what-is-eudamed-european-database-medical-devices) – the pillar post this status update companions.
- [How to register your startup as a manufacturer in EUDAMED](/blog/register-startup-manufacturer-eudamed) – the actor registration workflow once the module is usable.
- [What is the Single Registration Number (SRN)?](/blog/single-registration-number-srn) – the identifier at the heart of actor registration.
- [Device registration in EUDAMED](/blog/device-registration-eudamed) – the UDI/device registration workflow once you have an SRN.
- [What is a UDI?](/blog/what-is-udi) – the unique device identifier concept that the device registration module depends on.
- [MDR Articles 27-29 UDI requirements](/blog/mdr-articles-27-29-udi-requirements) – the legal obligations behind UDI assignment and submission.
- [The EUDAMED certificates module](/blog/eudamed-certificates-module) – how Notified Body certificates appear in EUDAMED.
- [The EUDAMED vigilance module](/blog/eudamed-vigilance-module) – how serious incident reports and FSCAs flow through EUDAMED.
- [EUDAMED and UDI compliance checklist](/blog/eudamed-udi-compliance-checklist) – the consolidated readiness list for the whole cluster.
- [MDR regulatory updates 2026](/blog/mdr-regulatory-updates-2026) – the wider regulatory calendar that EUDAMED declarations feed into.
- [The Subtract to Ship framework for MDR](/blog/subtract-to-ship-framework-mdr) – the methodology for cutting EUDAMED work down to what the articles require.

## Sources

1. Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, Article 29 (registration of devices), Article 30 (electronic system on registration of economic operators), Article 31 (registration of manufacturers, authorised representatives and importers), Article 32 (Summary of Safety and Clinical Performance), Article 33 (European database on medical devices. Eudamed), Article 34 (functioning of Eudamed), and Annex VI (information to be submitted for registration of devices and economic operators. Part A on manufacturer and economic operator data, Part B on device data, Part C on UDI data elements). Official Journal L 117, 5.5.2017.
2. Commission Implementing Regulation (EU) 2021/2078 of 26 November 2021 laying down rules for the application of Regulation (EU) 2017/745 of the European Parliament and of the Council as regards the European Database on Medical Devices (Eudamed). OJ L 426, 29.11.2021.
3. European Commission, EUDAMED information page. Current module status, Commission notices on functional declarations under Article 34, voluntary use announcements, user guides, and Official Journal references. Readers should consult this page directly on the day they act on any module-specific obligation, as module status is updated as each Commission functional declaration is published.

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*This post is a snapshot in time. The mechanism it describes. Article 34 functional declarations, staged module rollout, parallel national obligations during transition. Is stable. The specific mandatory status of any individual EUDAMED module is not. If the status has changed since the last updated date at the top of this post, the Commission's EUDAMED information page is the authoritative source and supersedes any time-sensitive statement here. Authored by Felix Lenhard and Tibor Zechmeister.*

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*This post is part of the [EUDAMED, UDI & Registration](https://zechmeister-solutions.com/en/blog/category/eudamed-udi) cluster in the [Subtract to Ship: MDR Blog](https://zechmeister-solutions.com/en/blog). For EU MDR certification consulting, see [zechmeister-solutions.com](https://zechmeister-solutions.com).*