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EUDAMED Registration Services for Medical Devices and IVDs

EUDAMED registration is the mandatory process of registering your company (actor registration and SRN) and your devices (Basic UDI-DI and UDI-DI) in the European database on medical devices. Since 28 May 2026 it is required before an MDR or IVDR device is placed on the EU market. I3CGLOBAL handles it end to end, as your EU Authorised Representative or as a standalone service.

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At a glance

What Is EUDAMED Registration?

EUDAMED is the European database on medical devices, set up by the European Commission under EU MDR 2017/745 and EU IVDR 2017/746. EUDAMED registration means entering your company data and device data into this database so that authorities, Notified Bodies, hospitals and the public can see who places which device on the EU market.

Key facts: two levels of registration (actor and device) · the SRN is your company’s EUDAMED ID · four modules mandatory since 28 May 2026 · devices already on the market must be registered by 28 November 2026 · non-EU manufacturers register through their EU Authorised Representative.

Question Short answer
Legal basis MDR Articles 29–31, 33 and 123; IVDR Articles 26–28, 30 and 113; Regulation (EU) 2024/1860 (gradual roll-out)
Company level Actor registration, which gives you a Single Registration Number (SRN)
Device level UDI/Device registration: Basic UDI-DI, UDI-DI, EMDN code and device data
Who validates Your national competent authority validates the actor data and issues the SRN
Cost of the database The European Commission does not charge to use EUDAMED. Check whether your national authority has its own fees.
Official source European Commission EUDAMED overview
Database structure

What Are the 6 EUDAMED Modules?

EUDAMED registration happens mainly in the first two modules. The others are used by Notified Bodies, authorities and, later, for vigilance and clinical investigations.

EUDAMED registration modules in 2026: actor, UDI device, Notified Bodies and certificates, market surveillance, vigilance and clinical investigations
Four of the six EUDAMED modules are mandatory since 28 May 2026.
Compliance dates

What Are the EUDAMED Registration Deadlines?

The Commission published the notice of functionality on 27 November 2025 (Decision (EU) 2025/2371). After a six-month transition, EUDAMED registration became mandatory.

Date What it means for you
28 May 2026 Actor, UDI/Device, Notified Body and certificate, and market surveillance modules mandatory. New MDR and IVDR devices must be registered before they are placed on the market.
28 November 2026 Deadline to register devices that were already on the market, including legacy devices still being sold
28 May 2027 Deadline for Notified Bodies to register certificates issued before May 2026
Not before 2028 Mandatory use of the vigilance and post-market surveillance module (Commission update, October 2026)

Running late? If your devices are on the EU market and not yet in EUDAMED, start now. Actor registration and SRN validation alone can take several weeks.

Scope

Who Needs EUDAMED Registration?

Economic operator EUDAMED registration obligation
EU manufacturers Register as an actor, obtain an SRN and register every device (Basic UDI-DI and UDI-DI)
Non-EU manufacturers Register as an actor through the EU Authorised Representative, who verifies the manufacturer’s data
EU Authorised Representatives Register as an actor and link to each non-EU manufacturer they represent. See our EC REP service.
Importers Register as an actor and check that the manufacturer and device are registered
System and procedure pack producers Register as an actor and register the systems or procedure packs they place on the market
Distributors Not required to register in EUDAMED

A Person Responsible for Regulatory Compliance (PRRC) must be named in your actor registration.

Step by step

How Does the EUDAMED Registration Process Work?

EUDAMED registration has two stages: first the company, then each device. Each step depends on the one before it, so the order matters. The Commission explains device registration on its UDI/Device registration page.

EUDAMED registration process in six steps from EU Login to SRN, UDI data and device registration
Company-level steps come first; device registration needs a valid SRN.
  1. Create EU Login accountsEach user needs an EU Login account to access EUDAMED.
  2. Submit the actor registration requestEnter company details, address, contact persons and PRRC. Non-EU manufacturers add their Authorised Representative mandate.
  3. Receive your SRNThe national competent authority checks the data and issues the Single Registration Number.
  4. Prepare UDI and EMDN dataAssign the Basic UDI-DI and UDI-DI through an issuing entity and choose the EMDN code for each device.
  5. Register devices and link certificatesRegister each Basic UDI-DI and its UDI-DIs, and link the Notified Body certificate or, for self-declared devices, the declaration of conformity.
  6. Choose the upload methodUse the web interface for small portfolios, XML bulk upload for larger ones, or machine-to-machine (M2M) data exchange.
  7. Keep data up to dateUpdate EUDAMED within 30 days of a change, and keep market status, certificates and contacts correct.
Preparation

Which Documents Do You Need Before You Start?

Most EUDAMED registration delays come from missing UDI codes, EMDN codes or certificate data. Have these ready before you start.

Document or data Needed for Notes
Company registration documents Actor registration Legal name, registered address, VAT or trade register number
PRRC details Actor registration Name and contact details of the PRRC
Signed EAR mandate Non-EU manufacturers Must be in place before the Authorised Representative can confirm you
Basic UDI-DI and UDI-DI Device registration From GS1, HIBCC, ICCBBA or IFA
EMDN code Device registration One European Medical Device Nomenclature code per device
Notified Body certificate Class IIa, IIb, III and IVD Class B, C, D Entered in EUDAMED by the Notified Body; you link your devices to it
EU declaration of conformity Class I and IVD Class A For self-declared devices
SSCP / SSP Implantable and Class III devices (MDR); Class C and D IVDs (IVDR) Validated and uploaded by the Notified Body
Planning

How Long Does EUDAMED Registration Take?

These are typical durations from our EUDAMED registration projects. Actual times depend on your country’s competent authority, your Notified Body and how complete your data is.

Activity Typical duration Depends on
EU Login and actor request 1–3 days Company documents ready
EAR appointment (non-EU only) 2–4 weeks Signed mandate agreement
SRN issued by the authority 1–4 weeks National competent authority validation
EMDN code mapping 1–2 weeks Complete device portfolio list
Basic UDI-DI and UDI-DI generation 2–4 weeks Issuing entity membership (GS1, HIBCC, ICCBBA or IFA)
Notified Body enters the certificate 1–3 weeks Your request to the Notified Body
Device registration and certificate linking 1–5 days SRN issued and certificate in EUDAMED
Total, simple portfolio 3–6 months Complete documentation at the start
Total, complex portfolio 6–12 months Many devices or classes, SSCP review or Notified Body delays
Regulations

How Do MDR and IVDR Requirements Differ in EUDAMED?

Topic EU MDR 2017/745 EU IVDR 2017/746
Device classes I, IIa, IIb, III A, B, C, D
Actor and device registration Articles 29 and 31 Articles 26 and 28
Self-declared (no Notified Body) Class I (not Is, Im, Ir) Class A non-sterile
Summary document in EUDAMED SSCP for implantable and Class III devices SSP for Class C and D devices
Post-market report PMS report (Class I), PSUR (IIa, IIb, III) PMS report (A, B), PSUR (C, D)
Legacy device guidance MDCG 2021-25 MDCG 2022-8
Our service

What Does Our EUDAMED Registration Service Include?

I3CGLOBAL is an EU Authorised Representative and regulatory consultancy with offices in India, Europe and the USA. Our EUDAMED registration service covers both the company and device levels, so you have one team for the full process.

Actor registration and SRN

EU Login set-up, actor request, PRRC data, AR mandate confirmation and follow-up with the competent authority until your SRN is issued.

UDI and EMDN preparation

Basic UDI-DI grouping, UDI-DI assignment support, EMDN code selection and a data check before upload.

Device registration

Web entry or XML bulk upload, certificate or DoC linking and coordination with your Notified Body.

Legacy devices

Registration of devices still sold under directive certificates, with EUDAMED-DI and EUDAMED-ID.

Ongoing maintenance

Updates within 30 days of changes, new devices, certificate renewals and market status changes.

Export documents

Once registered, we can help you obtain a free sale certificate for export markets.

Already have an EU Authorised Representative? We can also provide EUDAMED registration as a standalone service. See the EU Authorised Representative cost and EUDAMED registration fee pages for pricing.

Avoid rework

What Are the Most Common Registration Mistakes?

  • Starting device registration before the SRN is issued
  • Company name or address that does not match the certificate or declaration of conformity
  • Wrong Basic UDI-DI grouping, which forces new registrations later
  • Missing or wrong EMDN codes
  • Assuming the Notified Body certificate is already in EUDAMED without checking
  • Forgetting to register devices already on the market before 28 November 2026
  • Not updating EUDAMED within 30 days after a change

After registration

What Happens After Your Devices Are Registered?

Registration is not a one-time task. Once your company and devices are in EUDAMED, the data becomes part of the official EU record and others will rely on it.

Public visibility

Most actor and device data is published on the EUDAMED public site. Hospitals, distributors and authorities use it to check that your devices are compliant.

Importer and distributor checks

EU importers must verify that the manufacturer and device are registered. Missing data can stop your shipments.

Ongoing updates

Changes to company data, devices, certificates or market status must be updated. New UDI-DIs are needed when key device data changes.

Consistent data

Your EUDAMED data must match your technical documentation, labels and certificates. Notified Bodies and authorities can compare them at any time.

Vigilance module later

When the vigilance module becomes mandatory (not before 2028), incident reports and PSURs will also go through EUDAMED.

Export support

Many non-EU authorities ask for proof of CE marking. EUDAMED records and a free sale certificate support these applications.

Legacy devices

How Are Legacy Devices Included in EUDAMED Registration?

Legacy devices are devices still placed on the EU market under a valid certificate or declaration issued under the old directives (MDD, AIMDD or IVDD), as allowed by the MDR and IVDR transition rules. If you continue to sell them, they are part of your EUDAMED registration too.

  • Legacy devices are registered with a EUDAMED-DI and a EUDAMED-ID, which take the place of the Basic UDI-DI and UDI-DI used for MDR and IVDR devices.
  • Legacy devices still being sold must be registered by 28 November 2026.
  • Your company still needs an SRN, and non-EU manufacturers still register through their EU Authorised Representative.
  • MDCG 2021-25 (MDR) and MDCG 2022-8 (IVDR) explain which new-regulation requirements already apply to legacy devices.
Two levels

What Is the Difference Between Actor and Device Registration?

EUDAMED registration always has two parts. The actor registration is done once per company role; the device registration is repeated for every device and every relevant change.

Topic Actor registration UDI/Device registration
What is registered The legal entity and its role (manufacturer, AR, importer, SPPP) Each device: Basic UDI-DI, UDI-DI, EMDN code, certificate or DoC
Who submits Each economic operator for its own role The manufacturer, or its EU Authorised Representative if mandated
Who validates National competent authority Automatic checks; certificate links depend on Notified Body data
Result Single Registration Number (SRN) Device record, mostly visible on the EUDAMED public site
How often Once per role, then updates For every new device and every relevant change
Legal basis MDR Article 31 · IVDR Article 28 MDR Article 29 · IVDR Article 26

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Work with I3CGLOBAL

One Partner for EU Representation and EUDAMED Registration

Appoint I3CGLOBAL as your EU Authorised Representative and we complete your EUDAMED registration, UDI submission and updates as part of one service.

  • Actor registration and SRN follow-up
  • Basic UDI-DI, UDI-DI and EMDN preparation
  • Device and legacy device registration, including bulk XML
  • Maintenance, free sale certificates and EAR services

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Tell us your device classes, number of devices and target markets. We will send you a quote.

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FAQs

EUDAMED Registration: Frequently Asked Questions

What is EUDAMED registration?

EUDAMED registration is the process of entering your company (actor registration, which gives you an SRN) and your devices (Basic UDI-DI, UDI-DI and device data) in the European database on medical devices, as required by EU MDR 2017/745 and IVDR 2017/746.

Is EUDAMED registration mandatory?

Yes. The actor, UDI/Device, Notified Body and certificate, and market surveillance modules have been mandatory since 28 May 2026, under Commission Decision (EU) 2025/2371. New MDR and IVDR devices must be registered before they are placed on the EU market.

What is the deadline for devices already on the market?

Devices that were already on the EU market before 28 May 2026, including legacy devices still being sold, must be registered in EUDAMED by 28 November 2026.

What is an SRN and how do I get one?

The Single Registration Number (SRN) is your company’s unique ID in EUDAMED. You submit an actor registration request in EUDAMED, and your national competent authority checks the data and issues the SRN. You need it before you can register devices.

Do non-EU manufacturers need EUDAMED registration?

Yes. Non-EU manufacturers must appoint an EU Authorised Representative, who registers in EUDAMED and confirms the manufacturer’s actor registration. The manufacturer’s devices are then registered under its SRN.

Do distributors need to register in EUDAMED?

No. Distributors do not register in EUDAMED. Manufacturers, EU Authorised Representatives, importers and system or procedure pack producers do.

Who uploads the CE certificate to EUDAMED?

The Notified Body enters the certificate in EUDAMED. The manufacturer then links its Basic UDI-DIs to that certificate. For self-declared Class I and Class A devices, the declaration of conformity is used instead.

Does EUDAMED registration cost anything?

The European Commission does not charge to use EUDAMED. Some national authorities may charge their own fees, and consultants or EU Authorised Representatives charge for the registration service.

How long does EUDAMED registration take with I3CGLOBAL?

Once we have your signed mandate and company documents, actor registration and SRN are usually completed within 2 to 4 weeks, depending on the competent authority. Full device registration typically takes 3 to 6 months for a simple portfolio.

Can you handle only EUDAMED registration if we already have an EU Authorised Representative?

Yes. We offer EUDAMED registration and UDI submission as a standalone service, coordinating with your current EU Authorised Representative and Notified Body.

Can I start EUDAMED registration before my CE certificate is issued?

Yes, for actor registration. You need an SRN early, because Notified Bodies normally ask for it in the application. Device registration for certified devices is completed once the Notified Body has entered the certificate in EUDAMED.

Can one company have more than one SRN?

Yes. An SRN is issued per actor role. A company that is both a manufacturer and an importer, for example, receives a separate SRN for each role.

How do I log in to EUDAMED?

You log in with an EU Login account. Every person who works in EUDAMED for your company needs their own EU Login, and your company’s local actor administrator approves their access request in EUDAMED.

Can I check if a company or device is registered in EUDAMED?

Yes. Most actor and device data is published on the EUDAMED public site, where you can search by SRN, company name, Basic UDI-DI or UDI-DI.

Keep exploring

EUDAMED Registration Guides and Related Services

Updated | Author: Sobha Augustine, Founder, I3CGLOBAL | Reviewed by: Joe Kumar, I3CGLOBAL