EUDAMED: who must register, how the SRN is issued, and the deadlines since 28 May 2026

EUDAMED is the European database on medical devices. The Commission set it up under the Medical Device Regulation, Regulation (EU) 2017/745Regulation (EU) 2017/745, Medical Devices Regulation (consolidated text of 19 July 2026)The whole regulationClick opens the law on the EU Publications Office., and the in vitro diagnostic devices of Regulation (EU) 2017/746Regulation (EU) 2017/746, In Vitro Diagnostic Medical Devices Regulation (consolidated text of 10 January 2025)The whole regulationClick opens the law on the EU Publications Office. use the same database (Art. 33(1)Regulation (EU) 2017/745, Medical Devices Regulation (consolidated text of 19 July 2026)Article 33, paragraph 1Click opens the article on EUR-Lex.; IVDR Art. 30(1)Regulation (EU) 2017/746, In Vitro Diagnostic Medical Devices Regulation (consolidated text of 10 January 2025)Article 30, paragraph 1Click opens the article on EUR-Lex.). It holds three things a seller meets: the businesses behind a device, each registered once with a number; each device model, registered with its UDI; and the certificates notified bodies issue. Four of its parts have been mandatory since 28 May 2026.

Which EUDAMED modules are mandatory, and since when

EUDAMED is built from electronic systems the Regulation lists (Art. 33(2)Regulation (EU) 2017/745, Medical Devices Regulation (consolidated text of 19 July 2026)Article 33, paragraph 2Click opens the article on EUR-Lex.). The Commission presents them as six modules (European Commission):

Until 2024 the whole database became mandatory at once, and only when the last system worked. The delay of one system therefore held back all the others (Regulation (EU) 2024/1860, recitals 2 and 3). That act changed the rule. The Commission now verifies one or more systems at a time and publishes a notice for them (Art. 34(2)Regulation (EU) 2017/745, Medical Devices Regulation (consolidated text of 19 July 2026)Article 34, paragraph 2Click opens the article on EUR-Lex., Art. 34(3)Regulation (EU) 2017/745, Medical Devices Regulation (consolidated text of 19 July 2026)Article 34, paragraph 3Click opens the article on EUR-Lex.). The duties tied to a system apply “6 months from the date of publication of the notice” (Art. 123(3)(d)Regulation (EU) 2017/745, Medical Devices Regulation (consolidated text of 19 July 2026)Article 123, paragraph 3, point (d)Click opens the article on EUR-Lex.).

The notice for the first four systems is Commission Decision (EU) 2025/2371, published in the Official Journal on 27 November 2025 (Decision (EU) 2025/2371). The Commission gives 28 May 2026 as the first day of mandatory use (European Commission). From that date the national registration of devices and businesses under the old Directives stopped applying for these systems (Art. 123(3)(d)Regulation (EU) 2017/745, Medical Devices Regulation (consolidated text of 19 July 2026)Article 123, paragraph 3, point (d)Click opens the article on EUR-Lex., last subparagraph).

The two remaining modules have no voluntary period. Each will be released when it becomes mandatory, 6 months after its own notice. Until then, serious incidents are reported through the national processes (EUDAMED Q&A, Q12, Q13 and Q20).

Who must register in EUDAMED

The own-brand rule catches online sellers. A support or a thermometer bought from a factory and sold under your brand makes you its manufacturer, with every EUDAMED duty above (Art. 16(1)(a)Regulation (EU) 2017/745, Medical Devices Regulation (consolidated text of 19 July 2026)Article 16, paragraph 1, point (a)Click opens the article on EUR-Lex.). Which role you hold, and what each role owes beyond EUDAMED, is on EU MDR.

One business can hold several roles. Each role is a separate registration request and a separate SRN: a Belgian company that is both manufacturer and importer gets one SRN with the role code MF and one with IM (Commission infographic).

How the SRN is issued

The SRN is the single registration number of a manufacturer, an authorised representative or an importer. You send an actor registration request in EUDAMED with the data of Annex VI, Part A, Section 1 (Art. 31(1)Regulation (EU) 2017/745, Medical Devices Regulation (consolidated text of 19 July 2026)Article 31, paragraph 1Click opens the article on EUR-Lex.):

• your type of operator: manufacturer, authorised representative or importer;
• your name, address and contact details;
• the name, address and contact details of anyone who submits on your behalf;
• the name, address and contact details of your person responsible for regulatory compliance.

Every manufacturer and every authorised representative must have a person responsible for regulatory compliance available (Art. 15(1)Regulation (EU) 2017/745, Medical Devices Regulation (consolidated text of 19 July 2026)Article 15, paragraph 1Click opens the article on EUR-Lex., Art. 15(6)Regulation (EU) 2017/745, Medical Devices Regulation (consolidated text of 19 July 2026)Article 15, paragraph 6Click opens the article on EUR-Lex.); the qualifications that person needs are on EU MDR. The Commission also asks every actor to upload a signed declaration on information security responsibilities (European Commission).

The competent authority verifies the data, obtains the SRN from EUDAMED and issues it to you (Art. 31(2)Regulation (EU) 2017/745, Medical Devices Regulation (consolidated text of 19 July 2026)Article 31, paragraph 2Click opens the article on EUR-Lex.). For a business in the EU, that is the authority of the country it selects in its request. For a manufacturer outside the EU, the authorised representative verifies the request first, and the authority responsible for that representative issues the SRN. EUDAMED sends the number by email (Commission infographic). An SRN reads like BE-MF-000000001: a two-letter country code, the role, and nine digits (Commission infographic).

The manufacturer uses its SRN to apply to a notified body and to register its devices in EUDAMED (Art. 31(3)Regulation (EU) 2017/745, Medical Devices Regulation (consolidated text of 19 July 2026)Article 31, paragraph 3Click opens the article on EUR-Lex.). Your registration data are public (Art. 31(7)Regulation (EU) 2017/745, Medical Devices Regulation (consolidated text of 19 July 2026)Article 31, paragraph 7Click opens the article on EUR-Lex.). The competent authority may use them to charge you a fee (Art. 31(8)Regulation (EU) 2017/745, Medical Devices Regulation (consolidated text of 19 July 2026)Article 31, paragraph 8Click opens the article on EUR-Lex.); whether it does, and how much, each EU country sets.

What a manufacturer outside the EU needs before it can register

A manufacturer with no establishment in an EU country may place a device on the EU market only after designating a sole authorised representative (Art. 11(1)Regulation (EU) 2017/745, Medical Devices Regulation (consolidated text of 19 July 2026)Article 11, paragraph 1Click opens the article on EUR-Lex.). The representative is a person established in the EU with a written mandate from you, valid once it accepts it in writing, and covering at least all devices of the same generic device group (Art. 2(32)Regulation (EU) 2017/745, Medical Devices Regulation (consolidated text of 19 July 2026)Article 2, point 32Click opens the article on EUR-Lex., Art. 11(2)Regulation (EU) 2017/745, Medical Devices Regulation (consolidated text of 19 July 2026)Article 11, paragraph 2Click opens the article on EUR-Lex.). It registers in EUDAMED with its own SRN, and its mandate obliges it to verify that you have assigned UDIs and registered your devices (Art. 11(3)(c)Regulation (EU) 2017/745, Medical Devices Regulation (consolidated text of 19 July 2026)Article 11, paragraph 3, point (c)Click opens the article on EUR-Lex., Art. 31(1)Regulation (EU) 2017/745, Medical Devices Regulation (consolidated text of 19 July 2026)Article 31, paragraph 1Click opens the article on EUR-Lex.).

So the order is fixed: the representative first, then your own request. The request carries a mandate summary document (Commission template):

• your name and address;
• the representative’s SRN, name and address;
• the start date of the mandate, and its end date if one is set;
• whether the representative is mandated for vigilance;
• the generic device groups the mandate covers.

How the MDR representative differs from the GPSR responsible person, and who can hold each role, is on EU authorised representative.

What a seller outside the EU registers, and what the EU importer registers

An importer is a business “established within the Union” that places a device from outside the EU on the EU market (Art. 2(33)Regulation (EU) 2017/745, Medical Devices Regulation (consolidated text of 19 July 2026)Article 2, point 33Click opens the article on EUR-Lex.). A seller outside the EU cannot be the importer. If you only resell a device made by someone else, you are not its manufacturer, its representative or its importer, the three roles that register (Art. 31(1)Regulation (EU) 2017/745, Medical Devices Regulation (consolidated text of 19 July 2026)Article 31, paragraph 1Click opens the article on EUR-Lex.). You have no EUDAMED registration of your own. The device you sell does: its manufacturer, its representative where there is one, and the device itself must be in EUDAMED before it is placed on the market.

Your EU business customer who brings the devices in is the importer. It registers, checks that the device is registered, and adds its own details (Art. 13(4)Regulation (EU) 2017/745, Medical Devices Regulation (consolidated text of 19 July 2026)Article 13, paragraph 4Click opens the article on EUR-Lex., Art. 30(3)Regulation (EU) 2017/745, Medical Devices Regulation (consolidated text of 19 July 2026)Article 30, paragraph 3Click opens the article on EUR-Lex., Art. 31(1)Regulation (EU) 2017/745, Medical Devices Regulation (consolidated text of 19 July 2026)Article 31, paragraph 1Click opens the article on EUR-Lex.). A device the manufacturer has not registered may not be placed on the market at all (Art. 29(1)Regulation (EU) 2017/745, Medical Devices Regulation (consolidated text of 19 July 2026)Article 29, paragraph 1Click opens the article on EUR-Lex.). When you ship straight to buyers in the EU, there is no importer in the chain; what that leaves open is set out on EU MDR.

How a device is registered: Basic UDI-DI, UDI-DI and the device data

The UDI, the unique device identifier, has two parts. The UDI-DI identifies the manufacturer and the device model; the UDI-PI identifies the unit of production, such as the lot or serial number (Art. 27(1)Regulation (EU) 2017/745, Medical Devices Regulation (consolidated text of 19 July 2026)Article 27, paragraph 1Click opens the article on EUR-Lex.). The Basic UDI-DI is the primary identifier of a device model. It is the main key in the UDI database, and it appears on certificates and on the EU declaration of conformity (Annex VI, Part C, Section 1; Art. 27(6)Regulation (EU) 2017/745, Medical Devices Regulation (consolidated text of 19 July 2026)Article 27, paragraph 6Click opens the article on EUR-Lex.).

UDIs come from an issuing entity the Commission has designated (Art. 27(2)Regulation (EU) 2017/745, Medical Devices Regulation (consolidated text of 19 July 2026)Article 27, paragraph 2Click opens the article on EUR-Lex.). There are four: GS1, the Health Industry Business Communications Council (HIBCC), ICCBBA and IFA GmbH (Implementing Decision (EU) 2019/939, Annex); their designation runs until 27 June 2029 (Implementing Decision (EU) 2024/2120). Before placing a device on the market, the manufacturer assigns the Basic UDI-DI and sends it to the UDI database with the core data elements (Art. 29(1)Regulation (EU) 2017/745, Medical Devices Regulation (consolidated text of 19 July 2026)Article 29, paragraph 1Click opens the article on EUR-Lex., Annex VI, Part B), and enters the device registration data (Art. 29(4)Regulation (EU) 2017/745, Medical Devices Regulation (consolidated text of 19 July 2026)Article 29, paragraph 4Click opens the article on EUR-Lex., Annex VI, Part A, Section 2). Among them:

• the Basic UDI-DI and any further UDI-DIs, and the quantity per package;
• the manufacturer’s name and address and its SRN, and the authorised representative’s name and address, as on the label;
• the risk class and, where there is one, the notified body certificate: its data come from the notified body’s own entry, not from the manufacturer (Art. 29(4)Regulation (EU) 2017/745, Medical Devices Regulation (consolidated text of 19 July 2026)Article 29, paragraph 4Click opens the article on EUR-Lex.; Annex VI, Part A, Section 2.2);
• the EU country where the device is placed on the market and, for class IIa, IIb and III, every EU country where it is made available;
• the device’s code in the European Medical Device Nomenclature, EMDN;
• whether it is single-use, sterile or contains latex;
• its status: on the market, no longer placed on the market, recalled, or under a field safety corrective action.

One registration covers every unit sold under the same UDI-DI; lot and serial numbers are not entered (EUDAMED Q&A, UDI/DEV module). The UDI database holds no UDI-PIs and no commercially confidential product information, and its core data are public free of charge (Art. 28(2)Regulation (EU) 2017/745, Medical Devices Regulation (consolidated text of 19 July 2026)Article 28, paragraph 2Click opens the article on EUR-Lex., Art. 28(3)Regulation (EU) 2017/745, Medical Devices Regulation (consolidated text of 19 July 2026)Article 28, paragraph 3Click opens the article on EUR-Lex.). Where a notified body is involved, some device data become public only once the body has entered the certificate (EUDAMED Q&A, Q7).

Whoever puts together a system or procedure pack assigns it its own Basic UDI-DI and registers it before placing it on the market (Art. 29(2)Regulation (EU) 2017/745, Medical Devices Regulation (consolidated text of 19 July 2026)Article 29, paragraph 2Click opens the article on EUR-Lex.). When a first-aid kit counts as one is on EU MDR, and so are the dates from which the UDI must be on the label of each class.

Reading glasses get a simpler rule later. From 1 November 2028, one Master UDI-DI covers ready-to-wear reading spectacles with the same lens size and lens power, and the same goes for spectacle frames and lenses by their design parameters; a manufacturer may use it before that date (Delegated Regulation (EU) 2025/1920).

What applies to devices already on the market before 28 May 2026

A device first placed on the market before 28 May 2026, with more units placed on the market after that date, has to be registered “no later than 12 months from the date of publication of the notice” (Art. 123(3)(e)Regulation (EU) 2017/745, Medical Devices Regulation (consolidated text of 19 July 2026)Article 123, paragraph 3, point (e)Click opens the article on EUR-Lex.). This covers devices assessed under the Regulation, self-declared class I included, and legacy devices still sold under a Directive certificate or declaration (Art. 123(3)(e)(i)Regulation (EU) 2017/745, Medical Devices Regulation (consolidated text of 19 July 2026)Article 123, paragraph 3, point (e), point (i)Click opens the article on EUR-Lex., Art. 52(7)Regulation (EU) 2017/745, Medical Devices Regulation (consolidated text of 19 July 2026)Article 52, paragraph 7Click opens the article on EUR-Lex., Art. 123(3)(e)(ii)Regulation (EU) 2017/745, Medical Devices Regulation (consolidated text of 19 July 2026)Article 123, paragraph 3, point (e), point (ii)Click opens the article on EUR-Lex.). For legacy devices, the registration rules of the Regulation replace those of the Directives (Art. 120(3d)Regulation (EU) 2017/745, Medical Devices Regulation (consolidated text of 19 July 2026)Article 120, paragraph 3dClick opens the article on EUR-Lex.).

The notice was published on 27 November 2025. Under the EU rules on time limits, the day of publication is not counted and a period in months ends on the same date in the last month, so the period ends on 27 November 2026 (Regulation (EEC, Euratom) No 1182/71, Art. 3(1) and 3(2)(c)). The Commission’s timeline shows 28 November 2026 (Commission timeline). Registered by 27 November 2026, a device meets both readings.

Three cases need no registration (EUDAMED Q&A, Q8 and Q14):

• a device of which no unit is placed on the market from 28 May 2026, until a vigilance report on it has to go through EUDAMED;
• a legacy device that is “the same device” as one already registered under the Regulation, with the same identification, such as UDI-DI, catalogue number or trade name;
• a custom-made device.

A legacy device has no UDI duty under the Regulation. It is registered under an identifier EUDAMED issues, or under a UDI-DI it already has (EUDAMED Q&A, UDI/DEV module and footnote 14).

How to keep the registration current

Within one week of any change to your registration data, you update them. One year after you registered, and every second year after that, you confirm they are accurate. Miss that by more than six months, and any EU country may take corrective measures on its territory until you comply (Art. 31(4)Regulation (EU) 2017/745, Medical Devices Regulation (consolidated text of 19 July 2026)Article 31, paragraph 4Click opens the article on EUR-Lex., Art. 31(5)Regulation (EU) 2017/745, Medical Devices Regulation (consolidated text of 19 July 2026)Article 31, paragraph 5Click opens the article on EUR-Lex.). The competent authority verifies the confirmed data (Art. 31(6)Regulation (EU) 2017/745, Medical Devices Regulation (consolidated text of 19 July 2026)Article 31, paragraph 6Click opens the article on EUR-Lex.). Device data are kept updated the same way, including the device’s status (Art. 29(4)Regulation (EU) 2017/745, Medical Devices Regulation (consolidated text of 19 July 2026)Article 29, paragraph 4Click opens the article on EUR-Lex.).

What the public EUDAMED site shows

EUDAMED has a public site and a restricted one (European Commission). The public site is at ec.europa.eu/tools/eudamed. The data of registered manufacturers, authorised representatives and importers are public (Art. 31(7)Regulation (EU) 2017/745, Medical Devices Regulation (consolidated text of 19 July 2026)Article 31, paragraph 7Click opens the article on EUR-Lex.), and so are the core UDI data of each device (Art. 28(3)Regulation (EU) 2017/745, Medical Devices Regulation (consolidated text of 19 July 2026)Article 28, paragraph 3Click opens the article on EUR-Lex.). The Regulation asks for the public parts to be “user-friendly and easily-searchable” (Art. 33(5)Regulation (EU) 2017/745, Medical Devices Regulation (consolidated text of 19 July 2026)Article 33, paragraph 5Click opens the article on EUR-Lex.). An EU importer, a distributor or a marketplace can therefore see whether your SRN and your devices are there.

What applies to in vitro diagnostic devices

The IVDR uses the same database and the same rules. Manufacturers, authorised representatives and importers of IVDs register and get an SRN before placing a device on the market (IVDR Art. 28(1)Regulation (EU) 2017/746, In Vitro Diagnostic Medical Devices Regulation (consolidated text of 10 January 2025)Article 28, paragraph 1Click opens the article on EUR-Lex., Art. 28(2)Regulation (EU) 2017/746, In Vitro Diagnostic Medical Devices Regulation (consolidated text of 10 January 2025)Article 28, paragraph 2Click opens the article on EUR-Lex.). The manufacturer assigns a Basic UDI-DI and registers each device (IVDR Art. 26(1)Regulation (EU) 2017/746, In Vitro Diagnostic Medical Devices Regulation (consolidated text of 10 January 2025)Article 26, paragraph 1Click opens the article on EUR-Lex., Art. 26(3)Regulation (EU) 2017/746, In Vitro Diagnostic Medical Devices Regulation (consolidated text of 10 January 2025)Article 26, paragraph 3Click opens the article on EUR-Lex.). The importer checks the registration and adds its details (IVDR Art. 13(4)Regulation (EU) 2017/746, In Vitro Diagnostic Medical Devices Regulation (consolidated text of 10 January 2025)Article 13, paragraph 4Click opens the article on EUR-Lex., Art. 27(3)Regulation (EU) 2017/746, In Vitro Diagnostic Medical Devices Regulation (consolidated text of 10 January 2025)Article 27, paragraph 3Click opens the article on EUR-Lex.). Distributors do not register; an EU country may keep its own register (IVDR Art. 27(2)Regulation (EU) 2017/746, In Vitro Diagnostic Medical Devices Regulation (consolidated text of 10 January 2025)Article 27, paragraph 2Click opens the article on EUR-Lex.).

The same notice of 27 November 2025 covers the IVDR systems, so the same four modules are mandatory for IVDs since 28 May 2026 (IVDR Art. 113(3)(f)Regulation (EU) 2017/746, In Vitro Diagnostic Medical Devices Regulation (consolidated text of 10 January 2025)Article 113, paragraph 3, point (f)Click opens the article on EUR-Lex.). The deadline for IVDs already on the market is worded differently: “no later than 6 months from” the date the duties apply (IVDR Art. 113(3)(fa)Regulation (EU) 2017/746, In Vitro Diagnostic Medical Devices Regulation (consolidated text of 10 January 2025)Article 113, paragraph 3, point (fa)Click opens the article on EUR-Lex.), that is, six months from 28 May 2026: 28 November 2026. Registering by 27 November 2026 meets both Regulations. What else the IVDR requires of tests and their sellers is on IVDR.

What happens if you do not register

The Regulation puts registration before the sale: an actor registers, and a device is registered, “before placing a device … on the market” (Art. 29(1)Regulation (EU) 2017/745, Medical Devices Regulation (consolidated text of 19 July 2026)Article 29, paragraph 1Click opens the article on EUR-Lex., Art. 31(1)Regulation (EU) 2017/745, Medical Devices Regulation (consolidated text of 19 July 2026)Article 31, paragraph 1Click opens the article on EUR-Lex.). A device placed on the market without it does not comply.

In practice the chain stops it first. An importer must verify that the device is registered (Art. 13(4)Regulation (EU) 2017/745, Medical Devices Regulation (consolidated text of 19 July 2026)Article 13, paragraph 4Click opens the article on EUR-Lex.), and an authorised representative must verify that the manufacturer has registered its devices (Art. 11(3)(c)Regulation (EU) 2017/745, Medical Devices Regulation (consolidated text of 19 July 2026)Article 11, paragraph 3, point (c)Click opens the article on EUR-Lex.). An authority that finds a device does not comply, without an unacceptable risk, requires the business to end the non-compliance within a set period; if it does not, the authority restricts or prohibits its sale, or has it withdrawn or recalled (Art. 97(1)Regulation (EU) 2017/745, Medical Devices Regulation (consolidated text of 19 July 2026)Article 97, paragraph 1Click opens the article on EUR-Lex., Art. 97(2)Regulation (EU) 2017/745, Medical Devices Regulation (consolidated text of 19 July 2026)Article 97, paragraph 2Click opens the article on EUR-Lex.). Penalties are set by each EU country (Art. 113Regulation (EU) 2017/745, Medical Devices Regulation (consolidated text of 19 July 2026)Article 113Click opens the article on EUR-Lex.). Data not confirmed on time can bring corrective measures of their own (Art. 31(5)Regulation (EU) 2017/745, Medical Devices Regulation (consolidated text of 19 July 2026)Article 31, paragraph 5Click opens the article on EUR-Lex.).

What the law leaves open

• The last day for devices already on the market. The MDR counts 12 months from publication of the notice (Art. 123(3)(e)Regulation (EU) 2017/745, Medical Devices Regulation (consolidated text of 19 July 2026)Article 123, paragraph 3, point (e)Click opens the article on EUR-Lex.), and the EU rules on time limits make that 27 November 2026. The Commission’s timeline shows 28 November 2026, and its Q&A counts a period from a notice of 1 July as ending on 2 July the next year (EUDAMED Q&A, Q7). Meanwhile: register by 27 November 2026.
• A seller outside the EU shipping straight to buyers. No importer is in the chain, so no one adds importer details to the device’s EUDAMED entry. The manufacturer’s and the representative’s registrations are still required (Art. 11(1)Regulation (EU) 2017/745, Medical Devices Regulation (consolidated text of 19 July 2026)Article 11, paragraph 1Click opens the article on EUR-Lex., Art. 31(1)Regulation (EU) 2017/745, Medical Devices Regulation (consolidated text of 19 July 2026)Article 31, paragraph 1Click opens the article on EUR-Lex.). Meanwhile: sell only a device whose manufacturer, representative and device entry are in EUDAMED, and make the importer’s other checks yourself, as set out on EU MDR.
• The rules are being rewritten. The Commission proposed a simplification of the MDR and the IVDR on 16 December 2025. Its explanatory memorandum says the UDI and registration provisions are clarified, economic operators give a digital contact in EUDAMED, and some electronic systems may be set up outside EUDAMED (COM(2025) 1023). It is a proposal. Until an amending act is published in the Official Journal, the Regulation applies as it stands.