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Leading EU Representative for Medical Device providing EU Registration Service for Non European Medical Device Manufactures
EUDAMED Registration Services
EUDAMED Registration is an important requirement under the European MDR (EU) 2017/745 and IVDR (EU) 2017/746 regulations for manufacturers, authorized representatives, importers, and system/procedure pack producers placing medical devices and IVD devices in the European market. I3CGLOBAL supports manufacturers with EUDAMED Actor Registration, SRN application, UDI/Basic UDI-DI registration, and MDR/IVDR compliance support.
One partner. One process. Full compliance. As your EU Authorized Representative, we handle EUDAMED registration from start to market launch.
What is EUDAMED?
EUDAMED — the European Database on Medical Devices is the centralized information system established by the European Commission under EU MDR (Regulation 2017/745) and EU IVDR (Regulation 2017/746). It serves as the single platform where manufacturers, authorised representatives, importers, and Notified Bodies register and manage device data across the European Union. EUDAMED covers six interconnected modules (1) Actor Registration, (2) UDI and Device Registration, (3) Notified Bodies and Certificates, (4) Clinical Investigations, (5) Vigilance, and (6) Post-Market Surveillance, making device information transparent, traceable, and accessible to regulators, healthcare professionals, and the public.
Who Needs EUDAMED Registration?
Any economic operator placing a medical device or in vitro diagnostic device on the European Union market is required to register in EUDAMED. This includes manufacturers based in the EU as well as non-EU manufacturers who must appoint an Authorised Representative (EC REP) to act on their behalf. Importers bringing devices into the EU market are also required to register as actors in EUDAMED. Notified Bodies, Competent Authorities, and Sponsors of clinical investigations have their own registration obligations under the system. In practical terms, if your device carries a CE mark under EU MDR or EU IVDR or is in the process of obtaining one EUDAMED registration is a mandatory regulatory requirement, not optional.
| Who | EUDAMED Obligation |
|---|---|
| EU Manufacturers | Register as Actor and register all devices and UDI data in EUDAMED. |
| Non-EU Manufacturers | Must appoint an Authorised Representative (EC REP) who registers and acts on their behalf in EUDAMED. |
| Authorised Representatives (EC REP) | Register as Actor in EUDAMED and manage device registrations for non-EU manufacturers. |
| Importers | Register as Actor in EUDAMED before placing non-EU manufactured devices on the EU market. |
| Notified Bodies | Register CE certificates and conformity assessments directly into the Certificates module. |
| Clinical Investigation Sponsors | Register clinical investigations and related documentation in the Clinical Investigation module. |
EUDAMED Registration Process
Registering your medical device or in-vitro diagnostic device in EUDAMED is a structured, multi-phase process that begins at the company level and extends through the entire device lifecycle. For the continent of our readers to understand, we divided into four phases. They are Actor Registration, Data Preparation, Device Submission with Certificate Linking, and ongoing Lifecycle Maintenance in the exact operational sequence our EU Representative follow for our customer. Each step has dependencies on the one before it, so data quality and sequencing matter from the outset.
Register for an EU Login account via the European Commission authentication portal. This is the secure login credential required for the initial EUDAMED administrator before any other action can be taken.
Ensure your EC REP is registered in EUDAMED. The mandate agreement must be in place and the EC REP relationship formally registered. Non-EU manufacturers cannot proceed without this step.
Enter your company details, registered address, Contact Person, and PRRC (Person Responsible for Regulatory Compliance) information in the Actor Registration Module.
The National Competent Authority validates your submitted data and issues your SRN. This number is your legal identifier in EUDAMED and is required before any device-level submission can begin.
SRN must be obtained before any device registrationAssign the correct European Medical Device Nomenclature (EMDN) code to each product in your portfolio. This determines how your device is classified and searchable within EUDAMED.
Partner with an accredited issuing agency (GS1, HIBCC, ICCBBA, or IFA) to generate your Basic UDI-DI — the regulatory anchor grouping devices by intended purpose and risk class — and your UDI-DI, the specific model-level identifier.
Gather all valid CE certificates issued by your Notified Body. For Class I self-declared devices, prepare your EC Declaration of Conformity (DoC) instead. These documents are the foundation for the certificate-linking step ahead.
Choose between Manual Entry via the EUDAMED user interface, or XML Bulk Upload / M2M API for larger portfolios. API access requires prior technical onboarding with EUDAMED including test environment setup and certificate configuration.
Your Notified Body enters the official CE certificate directly into EUDAMED. Manufacturers do not upload certificates themselves. Confirm with your Notified Body that this has been completed before proceeding to Step 10.
Manufacturers do not upload certificates — your NB doesInput your Basic UDI-DI into EUDAMED and reference it to the certificate number already uploaded by your Notified Body. For Class I devices, log your Declaration of Conformity here instead.
Submit each individual UDI-DI and link it to its parent Basic UDI-DI. Capture all device-level attributes including packaging levels, EMDN codes, device status, and market countries.
For Class III devices and implantable Class IIb devices, upload the Summary of Safety and Clinical Performance (SSCP). For Class D IVDs, upload the Summary of Safety and Performance (SSP).
SSCP must be approved by your Notified Body before going liveVerify all data dependencies before submitting. Some records go live immediately after automated validation checks; others require NCA validation before becoming publicly visible. Review all linked references carefully before confirming submission.
EUDAMED registration is an ongoing obligation, not a one-time event. Keep all records current throughout the device lifecycle — market status changes, certificate renewals, recalls, withdrawals, and vigilance reporting via the Vigilance Module. PSUR and PMSR updates also connect to EUDAMED's PMS module and must be maintained accordingly.
EUDAMED Device Registration Enforced Now!
EUDAMED Registration is now mandatory under the EU Medical Device Regulation (MDR 2017/745) and the In Vitro Diagnostic Regulation (IVDR 2017/746). However, the full implementation of all modules of EUDAMED is delayed.
⊗ The “Actor Registration” module is fully operational and mandatory. All manufacturers, authorized representatives, importers, and system/procedure pack producers need to register in EUDAMED to obtain a Single Registration Number (SRN).
⊗ Other modules, such as UDI/Device Registration, will become mandatory after the full implementation of the database, which is expected by 2026.
While a few modules are already required, complete compliance with European database on medical device is expected once all modules are fully functional.
MDR vs IVDR EUDAMED Requirements
While both EU MDR (Regulation 2017/745) and EU IVDR (Regulation 2017/746) use EUDAMED as their central registration platform, the specific obligations, device classifications, and submission requirements differ between the two regulations. The table below outlines the key differences manufacturers need to be aware of when registering under each framework.
| Requirement | EU MDR 2017/745 | EU IVDR 2017/746 |
|---|---|---|
| Device Classification | Class I, IIa, IIb, III | Class A, B, C, D |
| UDI Registration in EUDAMED | ✓ Mandatory — all classes | ✓ Mandatory — all classes |
| Notified Body Required | Class IIa, IIb, III | Class B, C, D |
| Self-Declaration (No NB) | Class I only | Class A only |
| SSCP Upload | Class III + implantable Class IIb | Not applicable |
| SSP Upload | Not applicable | Class D only |
| PMCF Requirements | All implantable + Class III | Class C and D |
| Vigilance Reporting | Via EUDAMED Vigilance Module | Via EUDAMED Vigilance Module |
| PMS Reporting | PMSR (Class I) / PSUR (Class IIa–III) | PMSR (Class A–B) / PSUR (Class C–D) |
| Full EUDAMED Mandatory Date | Already in effect | Phased implementation ongoing |
Documents Required for EUDAMED Registration
Preparing the right documentation before you begin EUDAMED registration significantly reduces delays, rework, and dependency bottlenecks. Many domestic manufacturers underestimate the preparation involved particularly around UDI code generation, EMDN mapping, and the certificate-linking dependency on the Notified Body. The table below outlines every document required across all four registration phases, who is responsible for providing it, and whether it applies under EU MDR, EU IVDR, or both. (Foreign manufactures the EUDAMED Registration support provided by the European authorized Representative)
| Document | Required For | MDR / IVDR | Notes |
|---|---|---|---|
| EU Login Account Credentials | All actors | Both | Required before any EUDAMED access can be granted |
| Company Registration Documents | Actor Registration | Both | Legal proof of company existence and registered address |
| PRRC Appointment Letter | Actor Registration | Both | Person Responsible for Regulatory Compliance must be formally appointed |
| Signed EC REP Mandate Agreement | Non-EU Manufacturers | Both | Must be in place before EC REP registers on your behalf |
| CE Certificate | Device Registration | Both | Uploaded directly by Notified Body — not the manufacturer |
| EC Declaration of Conformity (DoC) | Class I / Class A Devices | Both | Self-declared devices only — no NB certificate required |
| Basic UDI-DI Code | Device Registration | Both | Generated via accredited issuing agency — GS1, HIBCC, ICCBBA, or IFA |
| UDI-DI Code | Device Registration | Both | Model-level identifier linked to the parent Basic UDI-DI |
| EMDN Code Mapping | Device Registration | Both | Correct nomenclature code must be assigned to each device |
| Technical Documentation Summary | Device Registration | Both | Referenced during registration — not uploaded directly into EUDAMED |
| SSCP (Summary of Safety and Clinical Performance) | Class III + implantable Class IIb | MDR only | Must be NB-approved before going live in EUDAMED |
| SSP (Summary of Safety and Performance) | Class D IVDs | IVDR only | Must be NB-approved before going live in EUDAMED |
| PMCF / PMSR / PSUR Documentation | Post-Market Phase | Both | Connected to EUDAMED PMS and Vigilance modules |
| Vigilance Reports (FSN / FSCA) | Post-Market Phase | Both | Submitted via EUDAMED Vigilance Module when required |
EUDAMED Registration Timeline
EUDAMED registration is not a single submission event, it is a sequenced process with dependencies at every stage. The timeline below reflects a realistic end-to-end registration journey for a typical medical device manufacturer. Actual timelines vary depending on device risk class, portfolio size, Notified Body responsiveness, and the completeness of documentation at the point of submission.
| Phase | Activity | Estimated Duration | Key Dependency |
|---|---|---|---|
| Phase 1 | EU Login Account Setup | 1–2 days | None — first step, no prior dependency |
| Phase 1 | EC REP Appointment (Non-EU only) | 2–4 weeks | Mandate agreement must be signed before EC REP can register |
| Phase 1 | Actor Registration Submission | 1–3 days | EU Login account and company documents must be ready |
| Phase 1 | SRN Issuance by NCA | 1–4 weeks | NCA validation — timeline varies by country |
| Phase 2 | EMDN Code Mapping | 1–2 weeks | Device portfolio inventory must be complete |
| Phase 2 | UDI Code Generation (Basic UDI-DI + UDI-DI) | 2–4 weeks | Issuing agency onboarding required (GS1, HIBCC, ICCBBA, or IFA) |
| Phase 2 | Certificate / DoC Compilation | 1–2 weeks | Notified Body must have issued valid certificates |
| Phase 3 | NB Uploads Certificate to EUDAMED | 1–3 weeks | Manufacturer must formally request this from the NB |
| Phase 3 | Basic UDI-DI Registration & Certificate Linking | 1–3 days | SRN obtained and NB certificate live in EUDAMED |
| Phase 3 | UDI-DI Registration & Linking | 1–5 days | Basic UDI-DI must be registered first |
| Phase 3 | SSCP / SSP Upload & NB Approval | 4–12 weeks | NB review and approval required before going live |
| Phase 4 | Final Validation & Go-Live | 1–3 days | All upstream dependencies must be resolved |
| Total | Single device, straightforward portfolio | 3–6 months | Assumes complete documentation at the start |
| Total | Complex portfolio, multiple device classes | 6–12 months | Larger portfolios, SSCP requirements, or NB delays |
Do you need an email containing full details within 2 minutes?
We are a European Authorized Representative for Medical Devices and IVD,s. I3CGlobal also provide EUDAMED Registration for all our Foreign manufacturers. Contact us for more details and pricing.
One partner. One process. Full compliance. As your EU Authorized Representative, we handle EUDAMED registration from start to market launch.
Frequently Asked Questions About EUDAMED
When should EUDAMED registration be completed in the regulatory process?
EUDAMED registration should be completed after technical documentation is prepared and before applying to a Notified Body for conformity assessment, where applicable. Completing EUDAMED registration early helps avoid delays in CE marking and ensures a smoother path to EU market launch.
What are the documents required for EUDAMED registration?
The following are the documents required:
- EAR Agreement (For manufactures Only)
- EAR Mandate (For manufacturers Only)
- Declaration of Conformity
- Manufactures Declaration
- PRRC details
Is appointing an EU Authorized Representative mandatory?
Yes. Non-EU manufacturers must appoint an EU Authorized Representative before initiating EUDAMED registration. The EAR acts as the legal contact within the European Union and is responsible for supporting regulatory compliance, including validation of the manufacturer’s actor registration in EUDAMED.
EUDAMED Registration Timeline?
The average timeline is 2 to 3 weeks.
Does UDI updating a must now?
Once the UDI/Device Registration module in EUDAMED becomes fully operational, manufacturers will need to update their device information in the system, including the UDI. Until then, UDI updates may be handled through national regulatory systems or databases, depending on the Member State’s provisions.
Can non-European manufacturers register in EUDAMED?
What is Basic UDI-DI?
Page updated on 18th May 2026 by Sara Moly and Approved by Joe Kumar