EUDAMED Registration: Complete Guide for Medical Device & IVD Manufacturers (2026 Deadlines)

Why EUDAMED Registration Matters Now

On 27 November 2025, the European Commission published Commission Decision (EU) 2025/2371 in the Official Journal of the European Union. This was not a draft proposal or a consultation document. It was a binding legal act confirming that four EUDAMED modules are fully functional and meet their design specifications. The publication triggered a six-month transition period under Regulation (EU) 2024/1860. On 28 May 2026, EUDAMED becomes mandatory.

What does "mandatory" mean in practice? It means that if your devices are not registered, if your economic operators do not have Single Registration Numbers (SRNs), and if your certificate data is not in the system, you cannot legally place devices on the EU market. This is not theoretical. EUDAMED transitions from a voluntary pilot system to an enforceable market access requirement.

This guide covers everything you need to know: what EUDAMED is, how it is structured, the exact deadlines that apply, how to register actors and devices, how legacy devices are handled, and what happens after registration. It also covers the parallel Swiss system, Swissdamed, which has its own deadlines in July 2026.

What Is EUDAMED?

EUDAMED (European Database on Medical Devices) is the centralized EU information system for medical devices and in vitro diagnostics. It is established under Article 34 of the Medical Device Regulation (EU) 2017/745 (MDR) and the corresponding provisions of the In Vitro Diagnostic Regulation (EU) 2017/746 (IVDR). The European Commission operates EUDAMED, and it serves as the single repository for device identification, economic operator registration, certificate data, vigilance information, clinical investigation data, and market surveillance activities across all EU and EEA member states.

Legal Basis

EUDAMED's legal foundation spans multiple articles of both regulations:

Legal Provision	MDR Article	IVDR Article	What It Covers
Electronic system for registration of devices (UDI)	Article 29	Article 26	UDI/Device registration
Registration of economic operators	Article 31	Article 28	Actor registration and SRN
Electronic system on notified bodies and certificates	Article 33(2)(a)-(b)	Article 27(2)(a)-(b)	NB registration and certificate data
Establishment of EUDAMED	Article 34	Article 30	Overall database architecture
Electronic system on vigilance and post-market surveillance	Article 33(2)(c)	Article 27(2)(c)	Vigilance reporting
Electronic system on clinical investigations	Article 33(2)(d)	Article 27(2)(d)	Clinical investigation data
Electronic system on market surveillance	Article 33(2)(e)	Article 27(2)(e)	Market surveillance

Purpose

EUDAMED serves multiple objectives:

• Traceability. The UDI system, combined with actor registration, creates end-to-end traceability from manufacturer through supply chain to patient. This is a fundamental shift from the fragmented national systems that existed under the MDD.
• Transparency. Public access to device information (including clinical investigation data, certificates, and the Summary of Safety and Clinical Performance) allows patients and healthcare professionals to make informed decisions.
• Regulatory coordination. Competent Authorities, Notified Bodies, and the European Commission share a single source of truth for device and operator data. This eliminates duplicate registrations and inconsistent records across member states.
• Vigilance support. Once the Vigilance and PMS module becomes functional, EUDAMED will serve as the backbone for serious incident reporting, field safety corrective action notifications, and trend reporting across the EU.
• Market surveillance. Competent Authorities use EUDAMED to track devices on their national markets, verify compliance, and coordinate enforcement actions.

EUDAMED Architecture: The Six Modules

EUDAMED is built around six modules. Four have been declared functional as of November 2025 and become mandatory in May 2026. Two remain under development.

Module 1: Actor Registration (Active, Mandatory May 2026)

The Actor Module registers all economic operators who play a defined role in the medical device supply chain. Upon successful registration, the operator receives a Single Registration Number (SRN), which serves as their unique identifier across all EUDAMED modules.

Who must register:

Actor Type	SRN Issued?	Legal Basis
EU Manufacturer	Yes	MDR Article 31(1), IVDR Article 28(1)
Non-EU Manufacturer	Yes (via AR's Competent Authority)	MDR Article 31(1), IVDR Article 28(1)
Authorized Representative (AR)	Yes	MDR Article 31(1), IVDR Article 28(1)
Importer	Yes	MDR Article 31(1), IVDR Article 28(1)
System/Procedure Pack Producer (SPPP)	Yes	MDR Article 31(2), IVDR Article 28(2)
Custom-made device manufacturer	Actor ID (not SRN)	MDR Article 31(2)

Key points about the Actor Module:

• If a company operates in multiple roles (e.g., it is both a manufacturer and an importer), it must register separately for each role and will receive a separate SRN for each.
• The Actor Module data is publicly searchable (except Competent Authority contact details).
• Registration must be validated by the relevant Competent Authority before the SRN is issued.
• For non-EU manufacturers, the AR must verify the registration before it is submitted to the Competent Authority.
• At least two Local Actor Administrators (LAAs) must be assigned before the UDI/Device Module becomes accessible.

Module 2: UDI/Device Registration (Active, Mandatory May 2026)

The UDI/Device Module is where manufacturers register device data. Each device is identified by its Basic UDI-DI (the "family" level) and its UDI-DI (the specific product/packaging level). This module stores the core data elements required under MDR/IVDR Annex VI Part B.

What is registered:

• Basic UDI-DI information: device group, risk class, intended purpose, EMDN nomenclature, certificate references
• UDI-DI information: specific product identifiers, packaging configurations, direct marking data, unit of use DI
• Device characteristics: sterilization status, single-use designation, latex content, storage conditions, clinical sizes
• Market information: member states where the device is placed on the market
• Legacy device information (for MDD/AIMDD/IVDD devices under transition)

Registration methods:

Method	Best For	Capacity
Manual entry via web interface	Small portfolios (under ~50 devices)	One device at a time
XML bulk upload	Medium to large portfolios	Up to 300 entities per XML file
Machine-to-Machine (M2M) API	Very large portfolios, automated systems	Continuous automated upload

Module 3: Notified Bodies and Certificates (Active, Mandatory May 2026)

This module centralizes information about Notified Bodies and the certificates they issue. Notified Bodies are responsible for entering and maintaining certificate data, not manufacturers. However, manufacturers benefit from this module because Basic UDI-DI registrations for devices that require Notified Body involvement must be confirmed by the Notified Body before the device record becomes "Registered" and publicly visible.

What is registered:

• Notified Body identification and scope of designation
• EU certificates issued under MDR/IVDR conformity assessment
• Certificate renewals, amendments, and supplements
• Certificate suspensions, restrictions, and withdrawals
• Reasons for any withdrawal or restriction (when applicable)

Key interaction with device registration: When a manufacturer submits a Basic UDI-DI for a device that requires Notified Body certification (i.e., anything above Class I under MDR, or Class A under IVDR), the device enters a "Submitted" state. The Notified Body must confirm the data before the status moves to "Registered." This verification step is built into the workflow.

Module 4: Market Surveillance (Active, Mandatory May 2026)

The Market Surveillance Module supports Competent Authorities in their surveillance activities. It is primarily used by national authorities, not by manufacturers directly. However, it interacts with the other modules because authorities use device and actor data from EUDAMED to conduct market surveillance checks.

What it covers:

• Documentation of surveillance activities and findings
• Coordination between national authorities on cross-border issues
• Tracking of corrective actions
• Support for the exchange of information under the Market Surveillance Regulation (EU) 2019/1020

Module 5: Clinical Investigations / Performance Studies (Under Development)

This module will register clinical investigations conducted under MDR and performance studies conducted under IVDR. It is not yet functional and no mandatory use date has been set. The European Commission has indicated that it is expected to be declared functional at a later date.

What it will cover:

• Clinical investigation applications and authorizations
• Performance study applications
• Investigation/study results and status updates
• Sponsor and investigation site information

Module 6: Vigilance and Post-Market Surveillance (Expected Q3 2026)

The Vigilance and PMS Module is expected to be declared functional in Q3 2026. It will become mandatory six months after its functionality notice is published in the OJEU, following the same phased approach as the first four modules.

What it will cover:

• Serious incident reports
• Field Safety Corrective Action (FSCA) notifications
• Periodic Safety Update Reports (PSURs)
• Trend reports
• Post-market surveillance summaries

Important implication: Once the Vigilance module becomes mandatory, you will not be able to submit serious incident reports or FSCA notifications unless your devices are already registered in the UDI/Device Module. This creates a practical incentive to register devices early, even before vigilance reporting becomes mandatory — especially for legacy devices.

Mandatory Timeline: All Deadlines

The mandatory timeline for EUDAMED is governed by two key legal acts: Regulation (EU) 2024/1860 (which introduced the phased module-by-module approach) and Commission Decision (EU) 2025/2371 (which declared the first four modules functional).

Timeline Overview

Date	Milestone	What It Means
9 July 2024	Regulation (EU) 2024/1860 enters into force	Legal framework for gradual EUDAMED rollout established; Article 10a supply disruption notification obligation applies from 10 January 2025
27 November 2025	Commission Decision (EU) 2025/2371 published in OJEU	Four modules declared functional; six-month transition period begins
28 May 2026	Mandatory use begins	Actor registration, UDI/Device registration, NB/Certificates, and Market Surveillance modules become mandatory
28 May 2026	New device registration deadline	Any device first placed on the market on or after this date must be registered in EUDAMED before placement on the market
28 November 2026	Legacy device registration deadline	All devices already on the market before 28 May 2026 that continue to be placed on the market must be registered by this date
28 May 2027	Notified Body certificate upload deadline	Notified Bodies must complete uploading all relevant pre-existing certificate information (18 months from the OJEU notice)
Q3 2026 (expected)	Vigilance/PMS module functionality notice	Expected publication of functionality declaration for the Vigilance module
Q1 2027 (expected)	Vigilance/PMS module becomes mandatory	Six months after functionality notice (estimated)
TBD	Clinical Investigations module	Still under development; no target date announced

What "Mandatory" Means for Each Stakeholder

For Manufacturers:

• You must have a valid SRN obtained through Actor registration before you can register devices.
• Every device placed on the EU market on or after 28 May 2026 must be registered in EUDAMED before it is placed on the market.
• Devices already on the market before 28 May 2026 must be registered by 28 November 2026 if they will continue to be placed on the market.
• Data in EUDAMED must be consistent with your technical documentation, labeling, IFU, and certificates.
• Any changes to core data elements must be updated within 30 days.

For Authorized Representatives:

• You must register and obtain an SRN.
• You must verify and approve the registration requests of non-EU manufacturers that have appointed you.
• You are the channel through which non-EU manufacturer registrations are validated (the Competent Authority in the AR's member state issues the SRN).

For Importers:

• You must register and obtain an SRN.
• You must link yourself to the non-EU manufacturers whose products you import.
• If the manufacturer is not yet registered, you should contact them to ensure they complete Actor registration before 28 May 2026.

For Notified Bodies:

• You must upload newly issued MDR/IVDR certificates as of 28 May 2026.
• You must upload all pre-existing relevant certificate information by 28 May 2027.
• You must confirm Basic UDI-DI data for devices under your conformity assessment.

Actor Registration (SRN): Step-by-Step

The Actor registration process differs depending on whether you are an EU-based economic operator or a non-EU manufacturer. Here is the detailed process for each.

Step 1: Create an EU Login Account

Every user who will interact with EUDAMED needs an EU Login account. EU Login is the European Commission's authentication service.

1. Go to the EUDAMED portal (webgate.ec.europa.eu/eudamed).
2. Click "Create your EU Login account."
3. Enter the required personal information (name, email, organization).
4. Complete the authentication setup (the account holder will receive confirmation via email).
5. The first person to register from your organization automatically becomes the Local Actor Administrator (LAA) for that actor.

Step 2: Initiate Actor Registration

1. Log in to EUDAMED with your EU Login credentials.
2. On the "User and Actor Registration" page, select the Actor Registration widget.
3. Read and accept the online disclaimer.
4. Enter the organization identification information:
   • Select the role (Manufacturer, Authorized Representative, Importer, or System/Procedure Pack Producer)
   • Select the country where the actor is established
   • Enter the legal organization name

The system will check for potential duplicates. If a match is found, you will be prompted to verify whether your organization is already registered.

Step 3: Complete the Registration Form

The registration form requires several categories of information:

Organization details:

• Legal name and any trade names
• Registered address (street, city, postal code, country)
• Contact details (phone, email, website)
• Organization type and size (SME status, if applicable)

Person Responsible for Regulatory Compliance (PRRC):

• Full name
• Qualifications (as required by MDR Article 15 / IVDR Article 14)
• Professional address and contact details
• Evidence of qualifications (uploaded as PDF)

Additional role-specific data:

• For EU manufacturers: Competent Authority of the member state where the manufacturer is established
• For non-EU manufacturers: identification of the Authorized Representative (by SRN or by name/country search)
• For importers: link to the non-EU manufacturer
• For SPPP producers: confirmation that the activity falls within the scope of MDR Article 22

Step 4: Verification and Validation

For EU economic operators (manufacturers, ARs, importers, SPPP producers established in the EU):

1. Submit the registration request.
2. The Competent Authority in the member state where you are established receives the request.
3. The Competent Authority reviews the data and may request corrections.
4. Upon approval, the SRN is issued automatically by EUDAMED.
5. You receive an email notification with your SRN.

For non-EU manufacturers:

1. Submit the registration request.
2. Your Authorized Representative receives a verification request.
3. The AR reviews the registration data and either approves or rejects it.
4. If the AR approves, the request is forwarded to the Competent Authority in the AR's member state.
5. The Competent Authority validates the request.
6. Upon approval, the SRN is issued and sent to both the non-EU manufacturer and the AR.

Step 5: Set Up User Accounts

After receiving your SRN, you must set up additional user accounts:

• At least one additional LAA. The UDI/Device Module will not activate until your actor has at least two LAAs assigned. This is a system requirement.
• Local User Administrators (LUAs) who can manage other user accounts.
• Linker profiles (for importers who need to link to non-EU manufacturers).
• Viewer profiles for read-only access to your actor data.

PRRC Requirements

The Person Responsible for Regulatory Compliance is a mandatory appointment under MDR Article 15 and IVDR Article 14. The PRRC must have specific qualifications:

For manufacturers and SPPP producers:

• A diploma, certificate, or other evidence of formal qualifications awarded on completion of a university degree or equivalent course of study in law, medicine, pharmacy, engineering, or another relevant scientific discipline
• At least one year of professional experience in regulatory affairs or quality management related to medical devices

For authorized representatives:

• The same qualification requirements as manufacturers
• At least one year of professional experience in regulatory affairs related to medical devices

For micro and small enterprises:

• The PRRC may be an external contractor, provided that person is permanently and continuously at the disposal of the manufacturer
• The qualification and experience requirements still apply

Required documents for PRRC registration:

• Copy of degree or diploma
• CV demonstrating relevant professional experience
• Proof of employment or contract with the organization

Note: All supporting documents must be uploaded in PDF format. The Competent Authority may request additional documentation during validation.

Required Documents for Actor Registration

Document	Format	Required By
Proof of company registration	PDF	All actors
PRRC qualification evidence	PDF	Manufacturers, ARs, SPPP producers
PRRC experience evidence (CV)	PDF	Manufacturers, ARs, SPPP producers
AR mandate agreement	PDF	Non-EU manufacturers
Any other supporting documentation	PDF	All actors (optional but recommended)

UDI/Device Registration

Once your actor registration is complete and you have at least two LAAs assigned, you can access the UDI/Device Module to register your devices.

Basic UDI-DI vs. UDI-DI

Understanding the distinction between Basic UDI-DI and UDI-DI is fundamental to EUDAMED registration. These are separate concepts with different roles in the system.

Concept	Basic UDI-DI (BUDI)	UDI-DI
Purpose	Groups devices with the same intended purpose, risk class, and essential design/manufacturing characteristics	Identifies a specific device version or model at the packaging level
Analogy	Device "family" identifier	Specific product identifier
Appears on packaging?	No — it is a regulatory identifier used in documentation, not on the physical label	Yes — it is part of the UDI carrier on the label and all packaging levels
Where it is referenced	EU DoC, technical documentation, certificates, SSCP	Label, IFU, implant card, purchase orders
Relationship	One Basic UDI-DI can link to many UDI-DIs	Each UDI-DI links to exactly one Basic UDI-DI
Issued by	GS1, HIBC, or other EU-designated issuing entity	Same issuing entities
Format	Depends on issuing entity (e.g., GS1: starts with 01 prefix for DI)	Depends on issuing entity

Data Elements Required for Device Registration

MDR/IVDR Annex VI Part B specifies the core data elements that must be provided alongside each UDI-DI. Here is what you need to prepare:

Basic UDI-DI level data:

1. Basic UDI-DI code
2. Issuing entity (GS1, HIBC, etc.)
3. Applicable legislation (MDR or IVDR)
4. Device risk class
5. EMDN code (European Medical Device Nomenclature) — must be at the most specific "leaf" level
6. Device trade name(s)
7. Intended purpose
8. Whether the device is an in vitro diagnostic
9. Whether the device is packaged sterile
10. Whether the device is single-use
11. Whether the device contains latex
12. Storage and handling conditions (if applicable)
13. Critical warnings or contraindications (if text appears on the label)
14. Whether clinical sizes are available
15. Certificate information: Notified Body name/number, certificate number, expiry date
16. Member State(s) where the device is placed on the market
17. Responsible for design (if different from registered manufacturer)
18. Responsible for manufacture (if different from registered manufacturer)
19. Product designer organization (if applicable)

UDI-DI level data:

1. UDI-DI code
2. Unit of use UDI-DI (if the UDI is not on the device at the unit of use level)
3. Quantity per package configuration
4. Method of production identification (expiry date, manufacturing date, lot number, serial number, or combination)
5. Direct marking UDI-DI (for devices requiring direct marking under MDR Article 27(4))
6. Packaging configuration hierarchy (if multiple packaging levels)

Packaging Hierarchy

EUDAMED supports hierarchical packaging structures. A single UDI-DI is assigned to each packaging level:

• Unit of use level — the individual device
• Sub-package level — a box containing multiple units
• Case level — a shipping case containing multiple sub-packages
• Pallet level — a pallet containing multiple cases (optional)

Each level gets its own UDI-DI, and they are all linked to the same Basic UDI-DI. The hierarchy must be maintained in EUDAMED to ensure traceability throughout the supply chain.

Bulk Upload Options

For manufacturers with large device portfolios, manual entry is impractical. EUDAMED provides two automated options:

XML Bulk Upload:

• Each XML file can contain up to 300 entities (Basic UDI-DIs, UDI-DIs, or a combination).
• The XML schema is published by the European Commission and must be followed exactly.
• A single error in an XML file can cause the entire file to be rejected. Validation is strict.
• Files are uploaded through the EUDAMED web interface.
• For a portfolio of 15,000 UDI-DIs, this means approximately 50 XML files.
• The Commission provides sample XML files in the EUDAMED technical documentation.

Machine-to-Machine (M2M) API:

• Uses the same XML format as bulk upload with additional authentication and envelope elements.
• Requires an Access Point (a certified intermediary server) to connect to EUDAMED's M2M gateway.
• Access Points are available from third-party providers at costs typically starting around EUR 5,000 per year for managed services.
• Before connecting to the production environment, you must successfully test in the EUDAMED Playground environment and submit proof of successful transactions.
• M2M is the best option for manufacturers who need continuous, automated data synchronization between their internal PLM/ERP systems and EUDAMED.

Recommended approach by portfolio size:

Portfolio Size	Recommended Method	Estimated Effort
1-50 devices	Manual web entry	1-2 weeks of focused work
50-500 devices	XML bulk upload	2-4 weeks (including data preparation and validation)
500-5,000 devices	XML bulk upload with tooling	1-3 months (requires data governance and batch management)
5,000+ devices	M2M API integration	3-6 months (requires IT project, Access Point setup, testing)

Legacy Device Registration

Legacy devices — those CE-marked under MDD, AIMDD, or IVDD and still benefitting from transitional provisions — have specific registration requirements under Regulation (EU) 2024/1860.

What Is a Legacy Device?

A legacy device is a medical device or IVD that:

• Was placed on the market under the MDD (93/42/EEC), AIMDD (90/385/EEC), or IVDD (98/79/EC)
• Continues to be placed on the market under the transitional provisions of MDR Article 120 or IVDR Article 110
• Meets the conditions for continued market access under Regulation (EU) 2023/607 (for medical devices) or Regulation (EU) 2024/1860 (for IVDs)

To qualify as a legacy device, all of the following conditions must be met:

• The device continues to comply with the applicable directive
• There are no significant changes to the design or intended purpose
• The devices do not present an unacceptable risk to health or safety
• The manufacturer has an MDR/IVDR-compliant quality management system in place by the applicable deadline
• The manufacturer has submitted a formal application to a Notified Body for MDR/IVDR conformity assessment by the applicable deadline
• The manufacturer has signed a written agreement with a Notified Body by the applicable deadline

Registration Requirements for Legacy Devices

Legacy devices present a unique challenge because they were certified under the old directives and may not have a Basic UDI-DI or UDI-DI assigned. EUDAMED handles this through specific provisions:

Devices that need to be registered:

• Legacy devices that will continue to be placed on the market after 28 May 2026
• Legacy devices for which a vigilance action (serious incident, FSCA, or trend report) is submitted — these must be registered immediately, even if the 28 November 2026 deadline has not yet passed
• Legacy devices that have been transitioned to MDR/IVDR (these are registered as MDR/IVDR devices, not as legacy devices)

Devices that do NOT need to be registered:

• "Old devices" — devices that are no longer placed on the market when the UDI/DEV module becomes mandatory (i.e., the manufacturer has stopped selling them)
• Custom-made devices (with limited exceptions for vigilance reporting)
• Devices that have already been registered under MDR/IVDR

Legacy device identifiers:

Legacy devices may not have a Basic UDI-DI because this concept did not exist under the MDD/IVDD. EUDAMED addresses this as follows:

• For legacy devices, EUDAMED assigns a EUDAMED-DI as the device identifier. This may be derived from an existing UDI-DI if one has been voluntarily assigned.
• If no UDI-DI exists, EUDAMED allocates an identifier.
• Manufacturers may continue to use existing identifiers (such as GTINs) provided no changes have occurred that could affect traceability.
• Identifiers created for legacy devices cannot be reused for MDR or IVDR-certified devices. Once a device transitions to full MDR/IVDR conformity, it must be registered as a new device with a new Basic UDI-DI.

Legacy Device Registration Approaches

Two approaches are available:

Approach 1: Voluntary UDI assignment. The manufacturer assigns a UDI-DI to the legacy device using a designated issuing entity. This provides a structured identifier that can be entered into EUDAMED. This is the preferred approach for manufacturers who plan to eventually transition the device to MDR/IVDR, as it establishes a UDI framework early.

Approach 2: EUDAMED-generated identifier. Where no UDI exists and the manufacturer does not wish to assign one, EUDAMED generates an identifier. This is simpler but provides less traceability and may create complications when the device eventually transitions to MDR/IVDR.

Transition Rules Under Regulation (EU) 2024/1860

The registration deadline for legacy devices is 28 November 2026 (12 months from the OJEU publication on 27 November 2025). However, the following exceptions apply:

• If a vigilance action (serious incident, FSCA, or trend report) concerns an unregistered legacy device, the device must be registered immediately. There is no grace period for vigilance-triggered registration.
• If a legacy device has already been registered under MDR/IVDR (because the manufacturer completed the conformity assessment transition early), no separate legacy registration is needed.
• If a legacy device is no longer being placed on the market, registration is generally not required — unless a vigilance action subsequently occurs.

Swissdamed: The Parallel Swiss System

Switzerland is not an EU member state and is not part of the EEA. Following the non-renewal of the Mutual Recognition Agreement (MRA) for medical devices in 2021, Switzerland has been building its own regulatory database: Swissdamed. If you sell devices in Switzerland, you must comply with both EUDAMED (for the EU market) and Swissdamed (for the Swiss market).

Swissdamed Architecture

Swissdamed has two modules, mirroring the EUDAMED modules most relevant to manufacturers:

Swissdamed Module	Equivalent EUDAMED Module	Status
Actor Module (CHRN registration)	Actor Module (SRN registration)	Available since August 2024
UDI Devices Module	UDI/Device Module	Available since August 2025 (voluntary until July 2026)

Swissdamed Deadlines

Date	Milestone
August 2024	Swissdamed Actor Module goes live
August 2025	Swissdamed UDI Devices Module goes live (voluntary)
1 July 2026	Device registration becomes mandatory for all devices placed on the Swiss market
31 December 2026	End of transition period for device registration
From 1 July 2026	Devices subject to serious incident, FSCA, or trend reporting must be registered immediately (no transition period)

CHRN: The Swiss Single Registration Number

The CHRN (Swiss Single Registration Number) is the Swiss equivalent of the EUDAMED SRN. It is issued by Swissmedic upon approval of an actor registration request. The following actors must obtain a CHRN:

• Swiss manufacturers
• Authorized Representatives established in Switzerland (CH-REP)
• Importers into Switzerland
• System and procedure pack producers in Switzerland

Key Differences Between EUDAMED and Swissdamed

Aspect	EUDAMED	Swissdamed
Jurisdiction	EU/EEA member states	Switzerland
Actor identifier	SRN	CHRN
Device registration	Mandatory from 28 May 2026	Mandatory from 1 July 2026
Legacy device deadline	28 November 2026	31 December 2026
Data connection	N/A (central system)	Not connected to EUDAMED
Upload format	Manual, XML, or M2M	Manual or XML (GET DEVICE/POST DEVICE format)
Registration fee	No fee	Fee expected from July 2026 (amount pending)
Representative	EU Authorized Representative	Swiss Authorized Representative (CH-REP)

Dual Maintenance Requirement

The two databases are not connected. Data cannot be transferred or synchronized between EUDAMED and Swissdamed. Companies active in both markets must maintain their data separately. However, because both systems use UDI-based and XML-structured data, much of the underlying data preparation can be reused — the same device information just needs to be formatted and uploaded to each system independently.

Step-by-Step Registration Walkthrough for a Manufacturer

Here is a complete walkthrough for a non-EU manufacturer registering in EUDAMED and registering a Class IIa medical device. This is the most common scenario.

Phase 1: Preparation (Before You Touch EUDAMED)

1. Confirm your regulatory route. Verify that your device is correctly classified and that your conformity assessment pathway is clear. Misclassification creates cascading problems.

2. Appoint an EU Authorized Representative. If you are not established in the EU, this is a legal prerequisite. Your AR must be registered in EUDAMED before you can submit your actor registration. Confirm with your AR that they have an SRN or are in the process of obtaining one.

3. Assign Basic UDI-DIs and UDI-DIs. Work with an EU-designated issuing entity (GS1, HIBC, ICCBBA, or IFA) to assign Basic UDI-DIs for your device families and UDI-DIs for each packaging configuration.

4. Compile your data package. Prepare all data elements required for both Actor registration and Device registration. Create a controlled internal data source — a spreadsheet or database — that maps every EUDAMED data field to your internal documentation.

5. Identify your PRRC. Ensure the person meets the qualification and experience requirements of MDR Article 15. Collect their diploma, CV, and proof of employment.

Phase 2: Actor Registration

6. Create your EU Login account at the EUDAMED portal.

7. Select Actor Registration and choose the "Manufacturer" role and your country of establishment.

8. Enter organization details — legal name, registered address, contact information.

9. Enter PRRC details and upload supporting documents (PDF only).

10. Identify your Authorized Representative — enter their SRN or search by name and country.

11. Submit the registration request. The system sends a verification request to your AR.

12. Your AR reviews and approves the registration data.

13. The Competent Authority in the AR's member state validates the request.

14. Receive your SRN via email notification.

15. Add a second LAA — without at least two LAAs, the UDI/Device Module remains inaccessible.

Phase 3: Device Registration

16. Access the UDI/Device Module from your EUDAMED dashboard.

17. Click "Register a New Device" and select the appropriate device type (MDR device, in this case).

18. Step 1: Basic UDI-DI main information. Enter the issuing entity, Basic UDI-DI code, applicable legislation (MDR), and risk class (Class IIa).

19. Step 2: Basic UDI-DI information. Enter EMDN nomenclature (at the leaf level), trade name, intended purpose, device characteristics (sterile, single-use, latex, storage conditions, critical warnings), certificate reference (NB number, certificate number, expiry date), and member states where the device is marketed.

20. Step 3: UDI-DI information. For each packaging level, enter the UDI-DI code, quantity per package, production identifiers (lot number, expiry date, serial number), and unit of use DI if applicable.

21. Review and submit. Because this is a Class IIa device requiring NB involvement, the Basic UDI-DI will enter "Submitted" status pending Notified Body confirmation.

22. Your Notified Body confirms the Basic UDI-DI data.

23. Device status changes to "Registered" and the data becomes publicly visible on the EUDAMED public website.

Phase 4: Post-Registration

24. Verify public data. Check the EUDAMED public website to confirm your device information is accurately displayed.

25. Update data as needed. Any changes to core data elements must be reflected in EUDAMED within 30 days. Examples include: new certificate issued, change in intended purpose, new packaging configuration, change of AR.

26. Register new devices before placing them on the market.

Common Mistakes and How to Avoid Them

EUDAMED registration is a data-intensive process, and errors are common. Here are the most frequent mistakes and practical strategies to prevent them.

1. Inconsistent Data Across Documents

The problem: The device name in EUDAMED does not match the name on the label, or the risk class in EUDAMED differs from the classification in the technical documentation, or the EMDN code does not align with the device description.

The fix: Establish a single controlled data source that feeds all outputs — EUDAMED entries, labels, IFUs, technical documentation, and certificates. Implement a field-level mapping between EUDAMED requirements and your internal controlled documents. Assign ownership of each data field to a specific person or function.

2. EMDN Code Selection Errors

The problem: EUDAMED requires an EMDN code at the most granular "leaf" level. Many manufacturers primarily use GMDN (Global Medical Device Nomenclature) and attempt to map GMDN codes to EMDN codes without regulatory review. Automated mapping without human oversight frequently produces incorrect leaf-level codes.

The fix: Manually review each EMDN code assignment. Use the EMDN browser on the EUDAMED public site to verify that the selected code accurately describes the device. Do not rely solely on automated crosswalks between GMDN and EMDN.

3. Basic UDI-DI Grouping Strategy Problems

The problem: Basic UDI-DIs are grouped incorrectly. Common errors include: grouping devices with different intended purposes under one BUDI, grouping devices with different risk classes, or grouping devices with materially different design characteristics.

The fix: Review your grouping strategy against the criteria in Annex VI Part C: devices under the same BUDI must share the same intended purpose, the same risk class, and the same essential design and manufacturing characteristics. If you discover grouping errors, be prepared to reassign BUDIs and update associated certificates and Declarations of Conformity.

4. Incomplete Legacy Device Registration

The problem: Legacy devices without UDI-DIs are registered with minimal data, or manufacturers assume legacy devices do not need to be registered at all.

The fix: All legacy devices that will continue to be placed on the market after 28 May 2026 must be registered by 28 November 2026. Proactively assign identifiers rather than relying on EUDAMED-generated IDs, which limit traceability and create complications during MDR transition.

5. Missing the Second LAA Requirement

The problem: A manufacturer completes Actor registration but cannot access the UDI/Device Module because they have only one LAA assigned.

The fix: Immediately after receiving your SRN, set up at least one additional LAA. This is a system requirement that catches many first-time users off guard.

6. AR Not Yet Registered

The problem: A non-EU manufacturer attempts to register but their AR has not yet completed Actor registration in EUDAMED. The AR must be registered before they can verify the manufacturer's registration request.

The fix: Coordinate with your AR early. Confirm that they have an SRN before you begin your registration. Build this into your project timeline.

7. XML Bulk Upload Errors

The problem: A single formatting error in an XML file causes the entire file (up to 300 entities) to be rejected. Common issues include incorrect date formats, missing mandatory fields, and special character encoding problems.

The fix: Validate every XML file against the published schema before uploading. Use the EUDAMED Playground environment to test uploads before submitting to production. Implement batch management to prevent duplicate uploads and version control issues.

8. Naming Inconsistencies

The problem: The manufacturer name on the label is "Acme Medical GmbH" but the EUDAMED actor registration uses "ACME MEDICAL GMBH" or "Acme Medical." Even minor variations can cause issues during Competent Authority validation or market surveillance checks.

The fix: Use the exact legal name as it appears on your certificate of incorporation. Cross-reference against your CE certificates and EU Declaration of Conformity. EUDAMED will check for duplicates, but near-matches can still cause confusion.

9. Not Planning for Vigilance-Triggered Registration

The problem: A manufacturer decides not to register a legacy device because it will be discontinued before November 2026. Then a serious incident occurs and the device must be registered immediately.

The fix: Register any legacy device that has a reasonable probability of being involved in a vigilance action. This includes any device with a history of incidents, devices still in active clinical use, and devices with known risks.

10. Under-Resourcing the Workstream

The problem: EUDAMED registration is treated as an administrative task assigned to a single person without adequate support. The scope is underestimated, particularly for large portfolios.

The fix: Treat EUDAMED as a regulatory project with defined milestones, allocated resources, and cross-functional involvement. Typical team composition includes regulatory affairs (data accuracy), IT (XML/M2M support), quality (documentation alignment), and a project manager.

Cost and Resource Planning

EUDAMED registration is not a trivial exercise. The effort depends on portfolio size, device complexity, and the registration method chosen.

Estimated Effort by Portfolio Size

Portfolio Size	Actor Registration	Device Registration	Ongoing Maintenance	Total Initial Effort
1-10 devices	1-2 days	2-5 days	0.5 day/month	1-2 weeks
10-50 devices	2-3 days	1-2 weeks	1-2 days/month	3-5 weeks
50-200 devices	3-5 days	2-4 weeks	2-3 days/month	1-2 months
200-1,000 devices	5-7 days	1-2 months	3-5 days/month	2-4 months
1,000+ devices	1-2 weeks	2-4 months	Ongoing (dedicated resource)	4-8 months

Cost Categories

Cost Category	Estimated Range	Notes
UDI issuance fees (GS1 membership, etc.)	EUR 500 - EUR 5,000/year	Depends on issuing entity and number of DIs
Internal labor (regulatory, QA, IT)	EUR 10,000 - EUR 100,000+	Depends on portfolio size and complexity
External regulatory consulting support	EUR 5,000 - EUR 50,000	For companies lacking internal capacity
M2M Access Point (if applicable)	EUR 5,000 - EUR 20,000/year	Third-party managed service
EUDAMED registration itself	No fee	The European Commission does not charge for EUDAMED registration
Swissdamed registration (Swiss market)	Fee pending (estimated CHF ~300 per device)	Swissmedic will levy fees from July 2026

Post-Registration Obligations

Registration is not a one-time event. The MDR and IVDR impose ongoing obligations on manufacturers and other economic operators to maintain accurate and current data in EUDAMED.

Data Update Requirements

Change Type	Update Deadline	Responsibility
Changes to core data elements that do not require a new UDI-DI	Within 30 days of the change	Manufacturer
New device variants or packaging configurations (new UDI-DI)	Before placing the device on the market	Manufacturer
Changes to actor data (address, PRRC, organization name)	Within 7 days	Actor (manufacturer, AR, importer, SPPP producer)
Certificate changes (renewal, amendment, suspension, withdrawal)	As entered by Notified Body	Notified Body
End of marketing for a device	Upon discontinuation (mark as "no longer placed on the market")	Manufacturer

Annual Reconfirmation

EUDAMED requires periodic confirmation that device data remains accurate. Manufacturers should implement an annual review process:

1. Review all registered Basic UDI-DIs and UDI-DIs for accuracy.
2. Confirm that trade names, intended purposes, risk classes, and certificate references are still current.
3. Verify that the member states where the device is marketed are up to date.
4. Confirm that the PRRC information is still accurate.
5. Update any data elements that have changed since the last review.
6. Document the review in your quality management system records.

Data Accuracy Obligations

Under MDR Article 31(3) and IVDR Article 28(3), economic operators are responsible for the accuracy of the data they enter in EUDAMED. Inaccurate or incomplete data can lead to:

• Competent Authority queries and potential delays in validation
• Inconsistencies between EUDAMED data and certificates, which may trigger market surveillance actions
• Reputational risk, since device data is publicly accessible
• Difficulty in submitting vigilance reports if device data does not match

Frequently Asked Questions

1. What is the difference between an SRN and an Actor ID?

An SRN (Single Registration Number) is issued to manufacturers, authorized representatives, importers, and system/procedure pack producers. A custom-made device manufacturer receives an Actor ID instead of an SRN, because custom-made devices are not registered in the UDI/Device Module. For most practical purposes, the Actor ID functions identically to the SRN — it uniquely identifies the actor in EUDAMED.

2. Can one company hold multiple SRNs?

Yes. If a company operates in multiple roles (for example, it is both a manufacturer and an importer), it must register separately for each role and will receive a separate SRN for each. The SRNs are tied to the role, not to the legal entity.

3. How long does Actor registration take?

For EU-based economic operators, the Competent Authority validation typically takes 1-4 weeks, depending on the member state. For non-EU manufacturers, the process adds an AR verification step before Competent Authority validation, which can add another 1-2 weeks. Build at least 4-6 weeks into your timeline for the full Actor registration process.

4. What if my Competent Authority rejects my Actor registration?

You will be notified of the rejection with reasons. You can correct the data and resubmit. Common reasons for rejection include: incomplete PRRC documentation, discrepancies in company registration details, and missing AR mandate agreements. Address the specific issues cited and resubmit.

5. Do I need to register Class I devices that are self-certified?

Yes. Class I devices (including measuring devices and sterile Class I devices that require NB involvement) must be registered in EUDAMED. The manufacturer must have an SRN and must enter device data in the UDI/Device Module. For Class I devices that do not require NB conformity assessment, the device enters "Registered" status immediately upon submission (no NB confirmation step).

6. What happens if I place a device on the market without registering it in EUDAMED after the mandatory date?

Placing an unregistered device on the EU market after 28 May 2026 constitutes non-compliance with MDR Article 29. Competent Authorities can take enforcement action, which may include requiring the device to be removed from the market, issuing a non-compliance decision, or initiating market surveillance measures.

7. Do I need a separate EUDAMED registration for each member state where I sell my device?

No. EUDAMED is a centralized EU-wide system. You register once and indicate which member states the device is placed on the market in. However, if you use different authorized representatives in different member states, each AR must be registered separately, and the device record must reference all applicable ARs.

8. How do I handle devices that are manufactured under contract (private label / OEM)?

In a private label arrangement, the company whose name appears on the label (the "manufacturer" under MDR Article 2(1)) is responsible for EUDAMED registration. The actual physical manufacturer is listed as the "organization responsible for manufacturing" in the device data. Both entities need SRNs if they are different legal entities.

9. Are custom-made devices exempt from EUDAMED?

Custom-made devices are exempt from UDI/Device registration, but the manufacturer still needs an Actor ID. However, there is an important exception: if a serious incident or field safety corrective action must be reported for a custom-made device, the device must be registered in EUDAMED to enable the vigilance report. This is relevant once the Vigilance/PMS module becomes mandatory.

10. What is the relationship between EUDAMED device registration and my CE certificate?

For devices above Class I (MDR) or Class A (IVDR), the Basic UDI-DI in EUDAMED must be confirmed by your Notified Body before the device record becomes publicly visible. The certificate details (NB number, certificate number, expiry date) are entered as part of the device data. Notified Bodies independently maintain certificate data in the NB/Certificates Module. Data consistency between the device record and the certificate record is critical.

11. Can I update device data after registration?

Yes. You can update non-core data elements at any time. Changes to core data elements must be made within 30 days. If a change requires a new UDI-DI (for example, a significant design change), you must register the new UDI-DI before placing the modified device on the market.

12. What is the EUDAMED public website and what information is visible?

EUDAMED has a public-facing website where anyone can search for registered devices, actors, and certificates. The public can see: device trade names, Basic UDI-DI, risk class, EMDN code, intended purpose, manufacturer name and SRN, certificate status, and the Summary of Safety and Clinical Performance (for Class III and implantable devices). Contact details of Competent Authorities are not publicly visible.

13. If a device is already registered under MDR, do I need to separately register it as a legacy device?

No. If a device has been fully transitioned to MDR/IVDR conformity and registered in EUDAMED as an MDR/IVDR device, no separate legacy registration is needed. Legacy registration applies only to devices that remain certified under the old directives.

14. What if my Notified Body has not yet uploaded my certificate to EUDAMED?

Notified Bodies must upload certificates for devices under their conformity assessment. If your NB has not yet uploaded your certificate data, contact them directly. The NB certificate upload deadline is 28 May 2027 for pre-existing certificates. Your device registration will remain in "Submitted" status until the NB confirms the Basic UDI-DI data.

15. Do importers need to register every device they import?

No. Importers register as actors (obtaining an SRN) and link themselves to the non-EU manufacturers whose products they import. The actual device registration is the manufacturer's responsibility. However, importers must ensure that the devices they import are registered in EUDAMED by the manufacturer.

16. How does EUDAMED interact with national registration requirements?

Under the MDD/IVDD framework, many member states required separate national device registrations. Once EUDAMED becomes mandatory, these national requirements are superseded by EUDAMED registration. You register once in EUDAMED and no longer need to submit separate national registrations in each member state. However, some member states may retain additional national requirements beyond the scope of EUDAMED (e.g., pricing and reimbursement listings).

17. What if I discover an error in my registered device data?

Correct the error immediately. Depending on the nature of the error, you may need to update the data in EUDAMED within 30 days (for core data element changes) or within 7 days (for actor data changes). If the error has compliance implications (e.g., incorrect risk class), you should also assess whether any corrective action is needed under your quality management system.

18. How do I handle devices with multiple trade names or brand names?

You can register multiple trade names under a single Basic UDI-DI, provided the devices share the same intended purpose, risk class, and essential design characteristics. However, if different trade names correspond to devices with different specifications, they require separate Basic UDI-DIs.

19. Are there fees for EUDAMED registration?

No. The European Commission does not charge fees for EUDAMED registration. However, there are indirect costs: UDI issuance fees from issuing entities, internal labor, potential consulting fees, and M2M Access Point fees if you choose automated integration. Swissdamed, by contrast, will charge a registration fee.

20. What should I do if my AR changes?

If you change your Authorized Representative, you must update your actor registration in EUDAMED. The new AR must be registered in EUDAMED. The old AR's link to your registration will be ended and the new AR's link established. Coordinate the transition carefully to avoid a gap where neither AR is linked, as this could affect your market access. Update the device records to reflect the new AR where applicable.

Key References

• Commission Decision (EU) 2025/2371 — Functionality declaration for the first four EUDAMED modules
• Regulation (EU) 2024/1860 — Gradual EUDAMED rollout, supply disruption notification, IVDR transition provisions
• Regulation (EU) 2017/745 (MDR) — Articles 29, 31, 33, 34; Annex VI (UDI and device data sets)
• Regulation (EU) 2017/746 (IVDR) — Articles 26, 28, 30; Annex VI
• MDCG 2019-4 — Timelines for registration of device data elements in EUDAMED
• MDCG 2018-1 v3 — Guidance on Basic UDI-DI
• MedTech Europe Guidance for Assigning Basic UDI-DI
• EUDAMED Actor Module User Guide (European Commission)
• EUDAMED UDI/Devices Module User Guide (European Commission)
• EU Commission Q&A on the Gradual Roll-Out of EUDAMED

Bottom Line

EUDAMED registration is no longer optional or theoretical. With Commission Decision (EU) 2025/2371 published on 27 November 2025, the countdown to mandatory use is active. The key dates are fixed: 28 May 2026 for actor registration and new device registration, 28 November 2026 for legacy devices, and 28 May 2027 for Notified Body certificate uploads.

Manufacturers who treat EUDAMED as a strategic regulatory project — with dedicated resources, cross-functional coordination, and structured data governance — will navigate the transition smoothly. Those who underestimate the effort or delay preparation risk missing deadlines, losing market access, and creating compliance gaps that compound over time.

If you sell devices in both the EU and Switzerland, factor Swissdamed into your planning. The parallel deadlines (EU in May, Switzerland in July) create a compressed window where both systems must be addressed simultaneously.

The most important step is to start now. Obtain your SRN, prepare your device data, validate your EMDN codes, and test your upload processes. EUDAMED is becoming the backbone of European device regulation. The manufacturers who are ready on day one will be the ones who maintain uninterrupted market access.

Related Guides

• EU MDR Notified Body & Conformity Assessment Guide — Understanding the NB designation process, conformity assessment routes, and certificate management.
• EU MDR / IVDR Complete Guide — Comprehensive overview of both regulations, including scope, classification, and transition timelines.
• Medical Device Technical File Guide — How to compile Annex II and Annex III technical documentation.
• Medical Device Labeling & UDI System Guide — UDI assignment, labeling requirements, and GUDID/EUDAMED database obligations.
• Post-Market Surveillance Guide — PMS plans, periodic safety update reports, and trend reporting.