EUROPE IT CONSULTING · EUDAMED RESOURCE GUIDE
EUDAMED links: official portals, documents and UDI tools
Looking for the EUDAMED login, an official guide or a tool for your Basic UDI-DI? This Europe IT Consulting resource directory points you to the right sources and explains how to use them.
Start with the key access points: the public EUDAMED website is for research, authorised production access is for working with real data, and the Playground is for testing. Below you will find registration guidance, legislation, guidelines and tools from the relevant publishers.
Editorial source check: · English-language destinations are identified accordingly; many EU pages offer additional languages.
Open EUDAMED: choose the right environment
Research information, edit real data or test a workflow: first choose the right environment.
EUROPEAN COMMISSION · PRODUCTION
Production login: work with data
Authorised access for working in EUDAMED. Use this entry point for actual registration and data operations; the actions available depend on your user profile.
EUROPEAN COMMISSION · PUBLIC SEARCH
Public search: find actors and data
Search publicly available EUDAMED information here. Use actor search to find an organisation or Actor ID/SRN. Public access does not grant editing rights.
EUROPEAN COMMISSION · TEST ENVIRONMENT
Playground: test workflows
The Playground is for testing and feedback. It is separate from production; a test registration is not a production submission. Features and access may differ between environments.
The official guide to EUDAMED environments explains the difference between Production and Playground. For current module status, use the central EUDAMED overview.
Registration and official user guidance
Actor registration, user access and technical help address different questions.
EUROPEAN COMMISSION · INFORMATION CENTRE
User manuals and technical documentation
The Information Centre brings together user guidance, technical documentation and EUDAMED questions. Select the appropriate section and check the environment and version covered by the guide.
EUROPEAN COMMISSION · MODULE PAGE
Prepare actor registration
Official entry point for registration applications and required documents. It links to declarations and templates for the relevant registration situation.
EUROPEAN COMMISSION · ROLE OVERVIEW
Clarify the role and Actor ID/SRN
The “Actor identifier / Single registration number” section explains Actor ID/SRN and links to the role overview. Organisation, role and identifier should be clear before data submission.
EUROPEAN COMMISSION · USER ACCESS
Request user access for an actor
A registered organisation and personal user access are different things. The “EUDAMED registered users” section explains access for people acting on behalf of an actor and links to “Users access requests”.
EUROPEAN COMMISSION · SUPPORT
Contact EUDAMED technical support
The official contact page leads to the support form. Use it to contact the EUDAMED support team; do not use the Europe IT contact form for an authority support ticket.
For practical context, see our EUDAMED FAQ. For a specific response, see the EUDAMED error library.
Legislation, guidelines and current status
Start with the source that fits your question. Legislation, a guideline and a user manual serve different purposes.
EUROPEAN COMMISSION · CURRENT OVERVIEW
EUDAMED overview and module status
The central overview explains the EUDAMED modules and their usage status. It is the first place to check which areas are already mandatory.
EUROPEAN COMMISSION · TIMELINE AND TRANSITIONS
Find timelines and transitional provisions
The overview contains “EUDAMED Timeline” and “Transitional period”. Check the case relevant to your products or certificates; a module launch is not a single deadline for all records.
EUROPEAN COMMISSION / MDCG · GUIDELINES
Select MDCG guidelines and UDI documents
The collection groups documents by topic, including UDI, Basic UDI-DI, Master UDI-DI and EMDN. Compare document number, revision and subject before using an older local copy.
EUR-LEX · LEGISLATION
MDR – Regulation (EU) 2017/745
The legislation for medical devices. This link opens the original act; for current questions, also consult amendments and the consolidated version offered by EUR-Lex.
EUR-LEX · LEGISLATION
IVDR – Regulation (EU) 2017/746
The legislation for in vitro diagnostic medical devices. Distinguish the original text from later amendments. Before deciding, check the applicable version and transitional provisions.
EUROPEAN COMMISSION · REGULATORY OVERVIEW
Understand the legal framework and amendments
This overview explains the MDR/IVDR framework and links to amendments, supplementary acts and proposals. A legislative proposal is not the same as law already in force.
EUROPEAN COMMISSION · SECTOR OVERVIEW
Medical devices in the European context
General introduction to the medical device sector and its European regulatory environment. For specific registration tasks, then use the EUDAMED-specific sources.
Want to understand the system first? We explain EUDAMED structure, modules and responsibilities.
Basic UDI-DI: GS1, HIBCC and IFA
Choose the tool of your issuing entity. GMN is the term used in the GS1 system, not a common name for all Basic UDI-DI generators.
GS1 · IDENTIFIER SYSTEM AND TOOL
GS1: Global Model Number (GMN)
In the GS1 system, the Basic UDI-DI is represented by the Global Model Number. The official guide explains its structure and links to the GMN generator. Use the tool appropriate to your GS1 system.
HIBCC · IDENTIFIER SYSTEM AND TOOL
HIBCC: HIBC Basic UDI-DI
HIBCC provides its own explanation of the HIBC Basic UDI-DI and access to its generator. HIBC Basic UDI-DI is not synonymous with the GS1 term GMN.
IFA · IDENTIFIER SYSTEM AND PORTAL
IFA: BUDI check-digit generator
The IFA page explains the elements of Basic UDI and points to the IFA portal for check-digit generation. You can sign in there or request a user account.
An identifier generator does not validate your entire EUDAMED record. Identifier generation, product data validation and submission are different tasks. Our glossary explains the terms: UDI/MDR/IVDR glossary.
Find EMDN codes, notified bodies and companies
A nomenclature code, a body’s designation and a company identifier are different search subjects.
EUROPEAN COMMISSION · NOMENCLATURE
EMDN: find nomenclature and codes
The official EMDN entry point provides background information, downloads and further help. An official guide is also available for searching in EUDAMED. Check the code’s version and status.
Open EMDN information and downloads
Official EMDN search guide
EUROPEAN COMMISSION · DIRECTORY
NANDO: find notified bodies
NANDO lists notified bodies. Check their designation for the required legal framework and scope of activity; a notified body is not the same as an EUDAMED actor registration.
Open the NANDO directory
Commission guidance and MDR/IVDR lists
DUN & BRADSTREET · NOT AN EUDAMED REGISTER
D-U-N-S / UPIK: supplementary company identification
UPIK is a separate company identification service using the D-U-N-S number. It replaces neither EUDAMED actor search nor Actor ID/SRN. Use it only if your specific process requires that identifier.
Supplementary and historical documents
For specialist questions and historical context. These sources do not replace the current entry points above.
EUROPEAN COMMISSION · GUIDANCE
Factsheets for manufacturers
The official “Getting ready for the new regulations” overview links to factsheets for medical device and IVD manufacturers. Check each document’s date; a factsheet does not replace current legislation and transitional rules.
EUR-LEX · SPECIALIST TOPIC
Reprocessing single-use devices – (EU) 2020/1207
Published legislation on common specifications for reprocessing single-use devices. This specific scope is not a general EUDAMED registration guide.
EUR-LEX · HISTORICAL CONTEXT
EUDAMED Decision 2010/227/EU
A document from the former EUDAMED legal framework. It remains accessible for historical context but is not a current user guide for today’s MDR/IVDR database.
EUR-LEX · HISTORICAL DEADLINE AMENDMENT
Amending Regulation (EU) 2020/561
This act documents amendments made in 2020. Do not use it on its own as today’s EUDAMED timeline; follow the sources above for current transitional arrangements.
Which source answers which question?
A quick guide to common search questions.
Where can I find the official EUDAMED login?
The production login is for actual operations. To look up published data only, use the public search. For tests, there is a separate Playground.
How do I know whether a guide still applies?
Check the publisher, revision, publication date and environment covered. For operating questions, use the Information Centre, for module status use the Commission overview and for legal questions consult the relevant legislation and amendments. A recently dated help page does not remove the need to check its content.
Does a Basic UDI-DI generator also validate EUDAMED data?
No. An identifier-generation tool is not equivalent to checking all product data or to acceptance of a submission. Read the relevant tool description from GS1, HIBCC or IFA.
What is the difference between legislation, guidelines and user help?
Legislation contains binding rules. Guidelines help interpret and apply them; user help explains how to operate the system. A generator or search tool supports a limited task. These source types complement each other but are not interchangeable.
FROM INFORMATION TO IMPLEMENTATION
Found the right source. What about your data?
Official documents explain requirements and operation. Your company must turn them into structured product data, traceable validation and a suitable submission process. Europe IT Consulting supports you in doing so.
With the Global Submission Portal the customer uploads a completed Excel template, receives automatic validation and initiates submission when validation reports no errors. GSP uses M2M for EUDAMED.
With GUDI in the SAP environment the customer submits directly from GUDI via M2M. For an agreed XML project process, Europe IT validates data, generates the XML files and then uploads them manually to EUDAMED.
