EUDAMED under the MDR and IVDR: The Six Modules, Who Must Register What and How the Public Site Works

The other two modules, vigilance and clinical investigations, are not yet in use, so EUDAMED is not fully functional.

The database concerns every party that places devices on the EU market or supervises that market. Manufacturers, authorised representatives and importers register as actors, system and procedure pack producers register as actors and enter their packs, notified bodies enter certificates, and competent authorities work in the market surveillance module. Distributors are the one economic operator that does not register in EUDAMED.

This page sets out the legal basis, maps the seven systems to the six modules with the status of each, and explains who registers what and from when. It then shows how the public site, the restricted site with EU Login and the Playground test environment work, how national databases relate to EUDAMED, where the pending revision stands, and what a listing in EUDAMED does not prove.

What Is EUDAMED?

EUDAMED (the European Database on Medical Devices, spelled "Eudamed" in the regulations) is the electronic system the European Commission sets up and controls to collect and publish information on devices, economic operators, certificates, clinical investigations, vigilance and market surveillance under both EU medical device regulations. The title of MDR Article 33 is "European database on medical devices", and EUDAMED is the short form the Commission uses for its pages, tools and support channels.

One database serves both regulations: the MDR (Regulation (EU) 2017/745) and the IVDR (Regulation (EU) 2017/746). Both regulations entered into force on 25 May 2017, the MDR has applied since 26 May 2021 and the IVDR since 26 May 2022, and both are directly applicable in every member state without national transposition. How EUDAMED fits into the framework of the EU MDR and IVDR is explained on the home page.

EUDAMED is not fully functional as of 6 November 2026. Four of its six modules are mandatory to use, while the vigilance module and the clinical investigations and performance studies module have no notice in the Official Journal yet. Actor, device and certificate data therefore go into EUDAMED today, while vigilance reporting and clinical investigations still follow the national processes that applied before.

The Legal Basis: MDR Articles 33 and 34 and IVDR Article 30

MDR Article 33 establishes EUDAMED and lists its systems, MDR Article 34 sets the functionality audit and the Commission notice, and IVDR Article 30 applies the same database to IVDs in accordance with MDR Articles 33 and 34. The IVDR therefore has no database of its own: in vitro diagnostic devices, their manufacturers and their certificates sit in the same modules as all other devices. Under MDR Article 34, the Commission publishes a notice in the Official Journal after an independent audit of a system's functionality, and the obligations linked to that system follow from the notice.

Commission Implementing Regulation (EU) 2021/2078 of 26 November 2021 (OJ L 426, 29.11.2021, p. 9), adopted under MDR Article 33(8) and in force since 19 December 2021, lays down the detailed rules for running EUDAMED. Its Article 2 sets three modes of access (the restricted website, the public website and machine-to-machine data exchange), and its Article 8 provides a contingency arrangement for malfunctions. The implementing regulation sets no mandatory-use date. Those dates come from Regulation (EU) 2024/1860, which rewrote MDR Article 34, MDR Article 123(3)(d) to (ec) and IVDR Article 113(3)(f) to (fd) so that each electronic system becomes mandatory on its own, in a gradual roll-out. Both EUDAMED articles sit in Chapter III of the EU MDR (Regulation (EU) 2017/745).

The Five Purposes the Database Serves

MDR Article 33(1) gives EUDAMED five purposes, points (a) to (e). The five purposes are listed below in the order of the article.

• Public information on devices placed on the market, on the certificates notified bodies issue and on the relevant economic operators (point (a)).
• Unique identification of devices within the internal market and their traceability (point (b)).
• Public information on clinical investigations (point (c)).
• Manufacturers' compliance with the information obligations of MDR Articles 87 to 90 on vigilance (point (d)).
• Tasks of the competent authorities and their cooperation with each other and with the Commission (point (e)).

The Commission is the controller of EUDAMED under MDR Article 33(9), so the Commission, not a member state, runs the database and answers for its data processing. MDR Article 33(5) adds that the parts of EUDAMED open to the public are presented in a user-friendly and easily searchable format, which is the legal basis of the public site described further down this page.

The Six EUDAMED Modules and the Seven Electronic Systems

MDR Article 33(2) lists seven electronic systems, and the Commission groups them into six modules because device registration and the UDI database run as one UDI/device registration module. The seven systems are the count in the law; the six modules are the way the Commission builds and opens the database, and each module has its own status and its own users. Device registration under MDR Article 29(4) and the UDI database of MDR Article 28 are two systems in law, points (a) and (b), but one module in practice, which is why the count drops from seven to six.

The IVDR uses the same structure. Under the IVDR (Regulation (EU) 2017/746) the same systems apply, with the electronic system on performance studies of IVDR Article 69 in place of clinical investigations, so one module covers clinical investigations and performance studies together. The table below maps each module to its MDR system and article, the IVDR counterpart, the status and the users.

Status as of 6 November 2026; the dated history of each module is on the EUDAMED timeline page listed below.

The Four Modules Already in Use

As of 6 November 2026, four modules are mandatory to use: actor registration, UDI/device registration, notified bodies and certificates, and market surveillance, all since 28 May 2026. Each of the four has its own users. Manufacturers, authorised representatives, importers and system or procedure pack producers register in the actor module. Manufacturers and pack producers enter device and pack data in the UDI/device registration module. Notified bodies enter certificates in the notified bodies and certificates module, and competent authorities and the Commission work in the market surveillance module.

The mandatory date follows from a two-step mechanism. Commission Decision (EU) 2025/2371, adopted on 26 November 2025 under MDR Article 34(3) and published in the Official Journal (OJ L, 2025/2371) on 27 November 2025, is the notice that the four systems work, and it entered into force on the day of publication. Its recitals refer to an independent audit report of 18 June 2025 and to the functional specifications, version 7.2 of 15 December 2022, against which the systems were audited. The obligations then applied 6 months after publication, under MDR Article 123(3)(d) and IVDR Article 113(3)(f) as amended by Regulation (EU) 2024/1860. The notice is a Commission decision, not an implementing regulation. Before 28 May 2026 three of the modules were open for voluntary use: actor registration since December 2020, and UDI/device registration and notified bodies and certificates since October 2021, the latter without the scrutiny mechanism and the clinical evaluation consultation procedure (CECP). The market surveillance module had no voluntary phase. Its access is restricted to competent authorities, with viewing for notified bodies where applicable, so manufacturers never use it.

Devices and certificates that existed before mandatory use have catch-up periods that differ by regulation. Devices already on the market, including legacy devices, that continue to be placed on the market are registered within 12 months of the publication of the notice under MDR Article 123(3)(e), and within 6 months from the mandatory-use date under IVDR Article 113(3)(fa). Notified bodies enter certificates issued before mandatory use within 18 months of the notice under MDR Article 123(3)(ea), and within 12 months from the mandatory-use date under IVDR Article 113(3)(fb). Only the latest version of each certificate, and the latest notified-body decision on it, is entered (MDR Article 123(3)(ea); Commission Q&A Q10).

The Vigilance and Clinical Investigation Modules: Not Yet in Use

The vigilance and post-market surveillance module is in development and the clinical investigations and performance studies module is under analysis; as of 6 November 2026, no Official Journal notice exists for either and neither has a voluntary phase. Both modules are released only when their use becomes mandatory, which happens 6 months after a future notice for each system.

Until each notice applies, the Directive provisions on vigilance and on clinical investigations, and the national processes built on them, continue to apply (MDR Article 123(3)(d), last subparagraph). The Commission Q&A on practical aspects of the gradual roll-out of EUDAMED, prepared by Commission services in November 2024 and not an MDCG document, points to MDCG 2021-1 rev.1 for MDR devices and MDCG 2022-12 for IVDs, which explain the interim practice while the vigilance module is missing; MDCG guidance is not legally binding. When the vigilance notice applies, the EUDAMED-based reporting duties it triggers include those of MDR Articles 87 and 88 and IVDR Articles 82 and 83 on serious incidents and trend reports. The vigilance and clinical data that the regulations plan for EUDAMED, such as serious incident reports and clinical investigation applications, therefore stay outside the database for now.

EUDAMED in Detail: Registration, Timeline and Nomenclature

Four detailed pages cover what this overview summarises: how actors register and get an SRN or Actor ID, how devices are registered, when each module became or becomes mandatory, and how the EMDN codes are used. The overview stays at the level of who registers what; identifier formats, update periods, fees, record details and the technical setup for data exchange belong to these four pages. Each of the four pages applies to both regulations and gives the MDR article and the IVDR article side by side. The table lists each page with the question it answers and its legal hook.

Who Must Register What in EUDAMED

Manufacturers, authorised representatives and importers register as actors before placing a device on the market, system and procedure pack producers register as actors too, manufacturers and pack producers register the devices, notified bodies enter certificates, and distributors do not register in EUDAMED. Registration in EUDAMED is split by role: the actor module records which economic operator is acting, the UDI/device module records what it places on the market, and the certificates module records what a notified body has certified. These EUDAMED duties have applied since 28 May 2026; before that date, use of the modules was voluntary, and registration followed the Directive provisions (MDR Article 123(3)(d), last subparagraph). The table below sets out each role, whether it registers as an actor, its identifier, whether it enters device data and the legal basis. The duties of each role beyond EUDAMED are set out under economic operators under the MDR and IVDR.

Manufacturers, Authorised Representatives and Importers

Under MDR Article 31(1) and IVDR Article 28, a manufacturer, an authorised representative or an importer submits its actor data before placing a device other than a custom-made device on the market, and, where a notified body is involved, before applying to it. The data to submit are those listed in MDR Annex VI Part A Section 1.

The competent authority verifies the data and issues the single registration number (SRN) through the electronic system (MDR Article 31(2), IVDR Article 28(2)). Actor data are public under MDR Article 31(7), so anyone can check on the public site whether an operator is registered. A manufacturer established outside the EU needs an active authorised representative and a mandate summary document before it can register: the authorised representative verifies the request, and the competent authority responsible for the authorised representative approves it and issues the SRN.

Importers carry a further check. Within 2 weeks of placing a device on the market, an importer verifies that the manufacturer or the authorised representative has entered its data in EUDAMED and adds its own details (MDR Article 30(3), IVDR Article 27(3)). The actor data also name who answers for regulatory compliance: they include the name, address and contact details of the person responsible for regulatory compliance (MDR Annex VI Part A Section 1.4).

Pack Producers, Sponsors and Other Special Cases

System and procedure pack producers register in the actor module and receive an Actor ID, not an SRN, before placing a system or procedure pack on the market (Commission Q&A Q4). The SRN belongs to the three roles of MDR Article 31 (manufacturers, authorised representatives and importers), so every other registered actor appears in EUDAMED with an Actor ID only.

Manufacturers that make only custom-made devices are exempt from actor registration before placing a device on the market. They register when a notified-body certificate or a vigilance report requires it, and they receive an Actor ID, not an SRN; MDCG 2021-13 rev.1 explains this in Q2 and Q3. Sponsors of clinical investigations and performance studies are the one group that cannot register yet, because their module has no notice.

Operators that no longer place devices on the market need no actor registration unless a vigilance or post-market surveillance action requires it (Commission Q&A Q5). MDCG 2021-13 rev.1, the MDCG question-and-answer document on actor registration, is listed in the MDCG guidance register.

Who Enters Device and Certificate Data

Only manufacturers enter device data and only system or procedure pack producers enter pack data; an authorised representative cannot register a device. The Commission's UDI/devices module presentation and the BfArM EUDAMED FAQ both state this split, so the authorised representative of a non-EU manufacturer registers itself as an actor and leaves the device records to the manufacturer.

Device registration happens before the first unit with a given UDI-DI is placed on the market on or after 28 May 2026 (MDR Article 29, IVDR Article 26; Commission Q&A Q7). One record per UDI-DI covers all units with different UDI-PIs, so a new lot or serial number needs no new registration. Custom-made devices, investigational devices, devices for performance studies and the devices the Commission Q&A calls "old devices" are not registered (Q&A Q7 and Q8).

Notified bodies enter the certificates they issue in the notified bodies and certificates module, the electronic system of MDR Article 57 and IVDR Article 52. For some devices, the device data become public only once the notified body has entered the certificate (Q&A Q7), so a manufacturer's device record and its notified body's certificate entry are linked steps.

Why Distributors Do Not Register

Distributors are not registered in EUDAMED: MDR Article 30(2) and IVDR Article 27(2) cover manufacturers, authorised representatives and importers, and leave member states free to keep or introduce a national registration of distributors. A distributor therefore holds no SRN and no Actor ID, and it enters no device data. The rule is identical under both regulations, so a distributor of IVDs is in the same position as a distributor of other medical devices. Where a member state keeps or introduces a national registration, the distributor registers in that national system, not in EUDAMED.

How the EUDAMED Public Site Works

The EUDAMED public site at ec.europa.eu/tools/eudamed shows the public parts of the database to anyone, without an account, in the user-friendly and easily searchable format that MDR Article 33(5) requires. It is the public website among the three modes of access of Implementing Regulation (EU) 2021/2078. What appears there depends on two things: only modules in use carry data, and only the data the regulations make public are shown. A reader who checks a registration on the public site therefore sees the actor, device and certificate data of the four modules in use, never the restricted data of the market surveillance module, and nothing yet from the two modules that have no notice.

What Anyone Can Search Without Logging In

Anyone can look up the actor data that MDR Article 31(7) makes public, the core UDI data that MDR Article 28(3) makes public free of charge, and the certificate information the notified bodies enter. All three data groups come from modules in mandatory use since 28 May 2026.

In practice the public site answers two common questions. The first is whether a manufacturer, an importer or an authorised representative is registered and holds an SRN: actor data are public, so any reader, for example a hospital buyer, a distributor or a competent authority of another member state, can check a registration. The second is which device stands behind a UDI-DI: devices are registered per UDI-DI, so the core data of a record can be found by its device identifier.

The public site shows data, not verdicts. A registered actor tells a reader that a competent authority verified the actor data before issuing the SRN, and a registered device tells a reader that the manufacturer entered the device data; neither tells the reader that a device conforms, as the last section of this page explains. The same searches apply to IVDs, because IVDR Article 30 runs EUDAMED under MDR Articles 33 and 34 and IVDR Article 28 mirrors the actor registration of MDR Article 31.

Downloading Public Data in Bulk

Public device data can be downloaded by anyone through a public download API in JSON format or as a bulk XML download, according to the Commission's UDI/devices module presentation. The legal hook is MDR Article 28(4), under which the UDI database is designed for automatic uploads and downloads. The two download routes serve users who need more than single searches, for example a hospital that matches its purchasing records against UDI-DIs or a researcher who analyses registered devices across manufacturers. Uploads work differently: only manufacturers and pack producers upload device and pack data, through the restricted site, and the upload routes are described in the restricted-site section below.

What the Public Data Leaves Out

The UDI database holds no UDI-PIs and no commercially confidential product information (MDR Article 28(2)), so serial numbers, lot numbers and expiry dates of individual units never appear on the public site. A UDI consists of a UDI-DI, which identifies the device, and a UDI-PI, which identifies the production unit; only the UDI-DI side goes into the database, and that is the identifier the public searches use. The same limit applies to IVDs, whose UDI database under IVDR Article 25 is part of the same UDI/device registration module.

Three further data groups are missing from the public site. Market surveillance data stay restricted to competent authorities, because the market surveillance module is an authority tool. Vigilance data and clinical investigation data have no module in use as of 6 November 2026, so serious incident reports and clinical investigation records are not published through EUDAMED today.

The Restricted Site, EU Login and the Playground

The restricted site at webgate.ec.europa.eu/eudamed is where registered users enter and manage data, and it needs an EU Login account; the Playground is a separate environment with dummy data for testing. Data entered on the restricted site go into Production, the environment with the real data of actors, devices and certificates, while the Playground holds dummy data only. The restricted site is also the first of the three modes of access of Implementing Regulation (EU) 2021/2078, next to the public website and machine-to-machine data exchange, and Article 3 of that implementing regulation governs how users register and gain access.

Who Logs In and What They Need

Actors, notified bodies and competent authorities log in to the restricted site with an EU Login account; a new actor's request leads to an Actor ID or SRN, which EUDAMED notifies by email. Every actor also signs a declaration on its information-security responsibilities. The competent authority then validates the actor request in the restricted site before the SRN is issued, so the login stage and the verification stage are separate steps.

Data reach EUDAMED by three input routes, according to the Commission's EUDAMED introduction presentation. The three routes are listed below.

• Web form: data entered record by record in the user interface.
• XML bulk upload: data files uploaded through the user interface.
• Machine-to-machine exchange: automated data exchange between an operator's own system and EUDAMED.

How bulk upload and machine-to-machine exchange work for device data is covered on the device registration page listed in the table of detailed pages above.

Testing in the Playground

The Playground is the EUDAMED test environment: it holds dummy data so users can try the functions before they use them in Production (Commission introduction presentation). A user can rehearse an actor request, a device record or a data upload there without creating a real record.

Machine-to-machine connections are tested in the Playground first and move to Production afterwards. For that step, the BfArM EUDAMED FAQ states that only proof that the machine-to-machine exchange works in the Playground is needed, not an upload of all data. The Commission has also announced a training environment, which would sit next to Production and the Playground. A record created in the Playground is not a registration under MDR Article 29 or MDR Article 31: only data entered in Production count, because only Production holds real data.

The Information Centre and Commission Support

The Commission's EUDAMED Information Centre at webgate.ec.europa.eu/eudamed-help holds the user guides and help pages, and the support address is SANTE-EUDAMED-SUPPORT@ec.europa.eu. For the rules behind the roll-out, the main written explainer is the Commission Q&A on practical aspects of the gradual roll-out of EUDAMED, prepared by Commission services in November 2024, with 20 questions in Parts A to C. MDCG 2021-13 rev.1 adds questions and answers on actor registration. Questions on the verification of an actor request in a given member state go to the competent authority that verifies the data and issues the SRN under MDR Article 31(2) and IVDR Article 28(2).

National Device Databases and EUDAMED

EUDAMED does not import data from national device databases, so every product is registered anew in EUDAMED (BfArM EUDAMED FAQ). A device notified in a national register before 28 May 2026 therefore needs its own EUDAMED record, created by the manufacturer within the catch-up periods for devices already on the market.

Germany is the national case covered here. The Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte, BfArM) switched off new product notifications in its national system DMIDS (the German medical devices information and database system) on 28 May 2026. Until then, §§ 96 and 96a of the German Medical Devices Implementation Act (Medizinprodukterecht-Durchführungsgesetz, MPDG) were the basis for those national notifications. DMIDS still handles other national procedures, such as applications for clinical investigations and performance studies and requests for special authorisations, according to BfArM. The national rules for Germany are set out under MDR and IVDR in Germany.

Two national layers continue next to EUDAMED. For vigilance and clinical investigations, the Directive provisions and the national processes stay in place until each EUDAMED notice applies, as the module section explains. For distributors, registration stays national wherever a member state keeps or introduces it under MDR Article 30(2) and IVDR Article 27(2).

EUDAMED Status Summary

As of 6 November 2026, four of six EUDAMED modules have been mandatory since 28 May 2026, the catch-up periods for devices already on the market and for certificates issued before mandatory use are running, and no notice exists for the vigilance or the clinical investigation module. The length of each catch-up period differs between the MDR, which counts from the publication of the notice, and the IVDR, which counts from the mandatory-use date, as the section on the four modules in use sets out.

A revision of the EUDAMED rules is pending: Commission proposal COM(2025) 1023 of 16 December 2025 (2025/0404(COD)), at the stage "Awaiting committee decision" in the European Parliament's SANT committee as of 6 November 2026; not law. The proposal would let the Commission decide that some electronic systems are interoperable with EUDAMED rather than part of it, would have national databases retrieve information from EUDAMED, and would have notified bodies upload certificates immediately. None of these proposed amendments applies today, and every amending act of the MDR and IVDR is listed under MDR and IVDR amendments.

The past procedural events in the European Parliament, as of 6 November 2026, include the draft report of the SANT committee of 30 June 2026 and the amendments of 28 July 2026. The proposal text on EUR-Lex and the procedure file 2025/0404(COD) are the primary sources for its wording and its stage. As long as the proposal is pending, the current MDR and IVDR rules described on this page are the ones that apply.

What EUDAMED Does Not Do

EUDAMED registers and publishes information; it does not certify a device, replace the conformity assessment or approve any company. Three limits follow from this: a listing proves no conformity, only the Commission addresses are EUDAMED, and personal data in the database can be corrected. Each limit applies equally under the MDR and the IVDR.

Does a Listing in EUDAMED Prove Conformity?

No: MDR Annex VI Part C Section 5 states that the presence of a UDI-DI in the UDI database shall not be assumed to mean that the device conforms to the Regulation. A device record shows that the manufacturer entered data, and an SRN shows that a competent authority verified actor data; neither is a certificate or a declaration of conformity. Conformity comes from the conformity assessment and is shown by the route that ends in CE marking for medical devices and IVDs.

Which Websites Are the Official EUDAMED?

The Commission runs EUDAMED at three addresses: the public site ec.europa.eu/tools/eudamed, the restricted site webgate.ec.europa.eu/eudamed and the Information Centre webgate.ec.europa.eu/eudamed-help. Search tools at other addresses are not the Commission database and are not a source for a registration status, because only the Commission database holds the data that actors, notified bodies and competent authorities enter. A registration status is confirmed on the EUDAMED public site itself, and the Commission's EUDAMED overview lists the public and the restricted site.

Correcting Personal Data Held in EUDAMED

A person whose data in EUDAMED are inaccurate or were processed unlawfully can ask for correction or deletion, and the request is dealt with within 60 days (MDR Article 33(7)). The right covers personal data such as the contact details entered for an actor or for a person responsible for regulatory compliance, and requests concern data that the Commission holds as controller under MDR Article 33(9).