EUDAMED FAQ

EUDAMED Questions and Answers

Updated: 31 August 2026. Since 28 May 2026 the use of the first four EUDAMED modules has been mandatory: Actor Registration, UDI/Devices, Notified Bodies & Certificates and Market Surveillance. For UDI/Device registration, specific transitional rules apply depending on when the device was first placed on the market. View the current status from the European Commission.

Table of contents

Actors & roles in EUDAMED

• Linking importer and manufacturer
• Registration as an importer
• Actor roles in EUDAMED
  

Device registration – fundamentals & deadlines

• Deadlines: When does EUDAMED become mandatory?
• Registration requirements for Class I devices
• UDI registration requirements for IVD devices
• Registration requirements for IVDD legacy devices

Device registration – practice & procedure

• Registering an individual device – step by step
• How device registration in EUDAMED works
• Editing devices already registered
• Changes to the device (name, trade name, etc.)
• Warnings & contraindications
• Changing a Basic UDI-DI retrospectively

Data structure & mandatory information

• Device model – what should be entered?
• Mandatory data for device registration
• Market information – date fields
• Country list: EU only?
• “Originally placed on the market” – meaning

Grouping & coding

• Grouping devices under one Basic UDI-DI
• GS1 codes for Legacy Devices
• Missing EMDN code – what to do?

GUI & system functions

• Functions in the EUDAMED GUI
• Excel upload & avoiding duplicate data maintenance
• Tool recommendation for manufacturers

National systems vs. EUDAMED

• Will EUDAMED replace national databases?
• Local databases that still need to be maintained

Question: Can an importer registered in EUDAMED link itself to a non-EU manufacturer without the manufacturer having to approve the link separately?

Yes. According to the current EUDAMED guidance, the importer can create the link itself. To do this, select “Link to non-EU manufacturer” in the Actor module, search for the manufacturer by Actor ID/SRN or name, and then confirm the link with a start date.
A separate approval or authorisation step by the manufacturer is not foreseen in this importer process as described. This must be distinguished from mandate management between a non-EU manufacturer and its EU authorised representative, where separate verification processes apply.
Official EUDAMED guidance on linking importers and manufacturers

Question: Most of our products fall under the manufacturer role, but there are some products that we place on the market in the importer role. For the importer role, I would like to know how registration is carried out.

Registration as an importer in EUDAMED – step by step

1. Understanding the importer role (pursuant to MDR Article 13):

An importer is a company established within the EU that places a device from outside the EU on the EU market – for example, devices from a non-EU manufacturer that it first imports into and distributes in the EU.

Important:

• Only necessary if you import devices from a non-EU manufacturer.

• If you are yourself a manufacturer established in the EU and distribute your own devices, you are not an importer within the meaning of the MDR.

📝 How do you register as an importer?

A. Step 1: Registration in the Actor module

1. Go to the EUDAMED Actor Registration Portal

2. Select “Importer” as the actor role.

3. Submit the actor registration to your national competent authority (in DE: BfArM, in FR: ANSM, etc.).

4. After approval, you will receive your SRN (Single Registration Number) as an importer.

📌 If you are already registered as a manufacturer, you must complete an additional, second registration as an importer – with a separate role, but possibly for the same company.

B. Step 2: Linking to non-EU manufacturers

• Once you have an SRN as an importer, you can link yourself to the relevant non-EU manufacturers whose devices you import into the EU.

• The link is created by the importer in the Actor module. A separate approval step by the manufacturer is not described in the current EUDAMED guidance for this linking process.

• This link is required so that the relevant devices are correctly associated in EUDAMED.

📌 Key obligations in the importer role (MDR Article 13):

Task	Description
Ensure MDR compliance	The importer must check whether the device bears the CE marking, whether instructions for use are available, etc.
Check UDI compliance	The packaging must carry the UDI label correctly
Ensure device traceability	The importer must document its supply chain
Check UDI/Device entries in EUDAMED	Imported devices must be properly registered
Cooperation with authorities	The importer must be able to report recalls, incidents, etc.

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🧠 Special case: combination of manufacturer & importer

If, for example, you manufacture your own devices (manufacturer role) and additionally import devices from a non-EU manufacturer under your own SRN, then:

• you must register twice: once as a manufacturer and once as an importer

• you must fulfil the importer obligations separately for the imported devices

• you may not register the same devices simultaneously as both manufacturer and importer – the allocation must be clear

📋 Additional note:

For device registration of imported devices, the non-EU manufacturer is responsible (Device module).
The importer is linked in the system as an Economic Operator, not as the primary registrant.

Question: How are the roles in EUDAMED clearly distinguished?

Clear distinction of roles in EUDAMED – who does what?

EUDAMED has 6 actor roles, but for device registration and obligations these 4 are the most important:

Role	SRN required?	Device registration possible?	Typical tasks
Manufacturer	✅ Yes	✅ Yes	Registers devices (UDI), manages device data, vigilance
Authorised Representative	✅ Yes	No (unless delegated by the manufacturer)	Represents non-EU manufacturers and can perform administrative tasks
Importer	✅ Yes	❌ No	Can create links to non-EU manufacturers in the Actor module and fulfils importer obligations under the MDR/IVDR (e.g. verification and traceability)
System/Procedure Pack Producer	✅ Yes	✅ Yes	Registers sets consisting of multiple devices

🔍 1. The “Manufacturer” role

• Has full control over device registration

• Must register every Basic UDI-DI and UDI-DI

• Can be both an EU or non-EU manufacturer (a non-EU manufacturer with a mandate through an EU Authorised Representative)

• Links devices with Economic Operators (importers, distributors)

• Responsible for vigilance reports, technical documentation, intended purpose, etc.

🔍 2. The “Importer” role

• Can register only if the company is established within the EU

• Does not register devices itself – but must:

  • Link itself to the manufacturer

  • Ensure that the devices it imports are registered in EUDAMED

  • Make its own company visible in the Economic Operator module

• Under Article 13 MDR, the importer must indicate its name or trade name, registered place of business and a contact address on the device, its packaging or an accompanying document. Article 13 MDR does not require the SRN to be stated on the label.

📌 The same company can be both a manufacturer and an importer – but in EUDAMED these are two separate roles, each with its own SRN.

🔍 3. The “Authorised Representative” role

• Required if the manufacturer is not established in the EU

• Is linked through a mandate declaration with the non-EU manufacturer

• Does not register devices itself, unless it performs this task on behalf of the manufacturer

👥 Linking the roles – practical example

So if you:

• are a manufacturer established in the EU → you register the devices yourself (UDI data, etc.)

• At the same time an importer for devices from a US manufacturer → you register separately as an importer, obtain your own SRN and link yourself to the US manufacturer

📄 In short: What does this mean for you?

If you…	Then you must…
manufacture your own devices in the EU	Register as a manufacturer and enter the devices yourself
import devices from third countries into the EU	Register additionally as an importer and link yourself to the manufacturer
act on behalf of non-EU manufacturers	Either act as an Authorised Representative or ensure a contractual relationship

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🎯 Conclusion:
EUDAMED is structured around clearly defined roles – and each role has its own tasks, obligations and its own SRN. As soon as a company assumes multiple roles, it needs clear internal processes and system assignments to avoid confusion or audit issues.

Question: When is use of the EUDAMED UDI/Devices module mandatory?

Use of the UDI/Devices module has been mandatory since 28 May 2026. The European Commission confirmed the functionality of the first four EUDAMED modules by the decision published in the Official Journal on 27 November 2025. Following the six-month transition period, mandatory use began on 28 May 2026.
For device registration, the date on which the device was first placed on the market is decisive:

• First unit of an MDR-/IVDR-compliant device from 28 May 2026 onward: As a general rule, the device must be registered in EUDAMED before being placed on the market.
• First unit already placed on the market before 28 May 2026: If further units are placed on the market after the cut-off date, the transitional rules apply; the EU timeline specifies 28 November 2026 as the registration deadline in the UDI/Devices module.

European Commission: current EUDAMED status

Question: What are the deadlines for registering Class I devices?

For MDR-compliant Class I devices, use of the UDI/Devices module has been mandatory since 28 May 2026.

• If the first unit of a new UDI-DI is placed on the EU market on or after 28 May 2026, the device must generally be registered in EUDAMED before being placed on the market.
• If the first unit was already on the market before 28 May 2026 and further units are placed on the market afterwards, the EU transitional timeline provides for registration no later than 28 November 2026.

The previous statement that the registration obligation would only begin in the future after a still-pending OJEU publication is therefore obsolete.

Question: Do I already have to use EUDAMED for UDI/Device registration under the IVDR?

Yes. Since 28 May 2026, the UDI/Devices module has also been mandatory for IVDR-relevant device registrations.
For new IVDR-compliant devices whose first unit is placed on the market from this cut-off date onward, registration is generally required before placing the device on the market. The corresponding transitional rules apply to devices already placed on the market before 28 May 2026.
European Commission: UDI/Device registration

Question: Do IVDD legacy devices also have to be registered in EUDAMED?

A blanket answer of “No” is no longer correct. Since the phased mandatory introduction of EUDAMED, specific registration rules for Legacy Devices apply under Regulation (EU) 2024/1860.
In particular, it matters when the device was first placed on the market and whether further units are made available on the EU market after 28 May 2026. The EU transitional timeline provides for Legacy Devices, or Regulation Devices already placed on the market before that date and for which further units are placed on the market after the cut-off date, to be registered in the UDI/Devices module by 28 November 2026.
Legacy Devices are not automatically subject to the same UDI labelling obligations as fully MDR-/IVDR-compliant devices. Special rules apply for identification in EUDAMED, for example using an EUDAMED DI/EUDAMED ID if no regular UDI-DI is available.
European Commission: registration of Legacy Devices in EUDAMED

Question: How do you register an individual Class I device?

Registering an individual device in EUDAMED – here is how:

1. Log in:
   https://webgate.ec.europa.eu/eudamed/

2. Open the UDI/Devices module

3. “Register new UDI/Device” select

4. Go through the wizard step by step (5 steps):

   • Step 1: Basic UDI-DI, Device Name, EMDN, risk class, intended purpose

   • Step 2: UDI-DI (GTIN), packaging, sterility

   • Step 3: Economic Operators (manufacturer, if applicable Authorised Representative/importer)

   • Step 4: market availability (“from” date, if applicable “to” date)

   • Step 5: validate & submit

5. Check status: the device is displayed as “Submitted” or “Published”

Question: How exactly do you register devices in EUDAMED?

Prerequisite:

• Your company is already registered in EUDAMED as a manufacturer and has an SRN (e.g. DE-MF-00000xxx)

• You have access to the EUDAMED GUI:
  👉 https://webgate.ec.europa.eu/eudamed/

🔄 1. Login & open module

1. Log in using the link above (EU Login).

2. In the dashboard, click on “UDI/Devices”

3. Select “Devices” in the menu and then:
   👉 “Register new UDI/Device”

✍️ 2. Device data entry – step by step in the wizard (5 steps)

📌 Step 1 – Basic UDI-DI information

• Basic UDI-DI: e.g. GS1 code (starting with 01…)

• Device Name: technical device name

• Brand Name (optional): trade name / brand

• EMDN Code: device nomenclature (e.g. W0101020105)

• Regulatory Reference: MDR or IVDR

• Risk Class: e.g. IIa, IIb, III (for IVD: A–D)

• Intended Purpose: intended purpose (free text)

• Notified Body (if applicable): incl. certificate number

📌 Step 2 – UDI-DI information

• UDI-DI: e.g. GTIN (linked to the Basic UDI-DI)

• Packaging: information on packaging levels (e.g. unit package, shipping carton)

• Sterility / Labeling Characteristics

• Storage / Shelf Life Information (optional)

• Contraindications / Warnings (optional, but recommended)

📌 Step 3 – Economic Operators

• Linking to other actors:

  • Importer (if applicable)

  • Authorised Representative (for non-EU manufacturers)

  • System/Procedure Packager (if relevant)

📌 Step 4 – Upload documents (optional)

• Option to upload technical attachments (label, IFU, etc.)

• Not mandatory for the initial registration

📌 Step 5 – Validation & submission

• You receive an overview of all data

• Click on “Validate” → the system checks the data structure

• Then click on “Submit”

3. What happens after submission?

Status	Meaning
Submitted	Registration has been submitted
Under Review	May still be reviewed by the authority
Published	The entry is officially visible in the system
Rejected	Incorrect submission – you receive information on what needs to be corrected

⚠️ Typical sources of error during registration:

• Basic UDI-DI does not match the UDI-DI (GTIN has already been used)

• EMDN code is missing or incorrect

• Not all mandatory fields have been completed (especially Intended Purpose)

• Incorrect formatting of date or number fields

📁 Alternatives to manual entry via the GUI:

• Bulk registration via XML (EU XSD schema)

• Automated M2M

Question: How can registered devices be edited afterwards?

✅ How to edit a device already registered in EUDAMED:

1. Log in to EUDAMED
   👉 https://webgate.ec.europa.eu/eudamed

2. Open the UDI/Devices module

3. Search for the device using UDI-DI or Basic UDI-DI

4. To the right of the entry, click on “Actions” → “Update”

5. Go through the wizard and change the required fields

6. Validate and then Submit – the update is submitted and processed

📌 Important:

• You can edit only devices that are linked to your manufacturer SRN

• Some fields (e.g. Basic UDI-DI) cannot be changed – if necessary, create a new device instead

Question: What is the relationship between tasks (e.g. changing the device name or adding a trade name) and the corresponding actions in the EUDAMED GUI, and what is the logical sequence of activities/actions in the GUI?

Typical examples of changes in the GUI

Change	Affected field (GUI)	EUDAMED module	Required action
Change device name	“Device Name”	UDI/Device module	Update Submission
Add trade name	“Brand Name”	UDI/Device module	Update Submission
Adjust model number	“Model”	UDI/Device module	Update Submission
Adjust intended purpose	“Intended Use”	UDI/Device module	Update Submission
Add packaging information	“Packaging”	UDI/Device module	Update Submission
Change sterility/label data	“Device Characteristics”	UDI/Device module	Update Submission

🖥️ Process in the GUI – recommended sequence of steps

🎯 Scenario: You want to change/add the device name AND trade name

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🔄 1. Log in & select device

• Go to the UDI/Device module

• Search for the relevant UDI-DI (GTIN)

• Click on “Actions” → “Update”

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✍️ 2. Step-by-step adjustment in the wizard

The GUI is divided into steps – the following fields are relevant:

Step 1: Basic UDI-DI & Device Information

• Here you can Device Name and Brand Name adjust

• You can also add several trade names here (e.g. for multilingual markets)

Step 2: Device Characteristics

• Check whether the name change affects other data (e.g. label language, packaging)

Steps 3–5: Review and Submit

• After the last page, you can review your entries

• Click on “Validate” → the system checks whether all mandatory fields are correct

• Then click on “Submit”

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🔐 3. After submission

• The status of the change is displayed as “Under Review” or “Updated”
• Some changes appear immediately, others only after approval by the competent authority (depending on the field and national implementation)

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⚠️ Important notes on sequence & logic

• Device Name vs. Brand Name:
  • Device Name = technical device designation
  • Brand Name = commercial brand name on the market (e.g. “MediPlus®”)
• Multiple Brand Names are possible, whereas the Device Name is not → therefore choose Brand Names carefully
• Changes to the Device Name or Brand Name may affect the label, IFU or technical documentation – therefore coordinate internally in advance
• You can combine several changes in one Update Submission – this is more efficient than submitting each change separately

Question: Could you please provide examples of critical warnings or contraindications (Step 4: UDI-DI characteristics)?

In this field, the manufacturer should enter relevant warnings or contraindications for the device, where applicable. The objective is to make patient and user safety directly visible.

✅ Examples of typical critical warnings:

• “Not suitable for use in patients with an implanted defibrillator.”

• “Do not use near magnetic resonance imaging (MRI) equipment.”

• “For use by trained healthcare professionals only.”

• “Sterile – do not use if the packaging is damaged.”

✅ Examples of contraindications:

• “Do not use in patients with a known latex allergy.”

• “Not suitable for children under 3 years of age.”

• “Do not use on open wounds or skin conditions in the application area.”

• “Do not use in pregnant or breastfeeding women.”

⚠️ Important:

• If there are no warnings or contraindications, the field can be completed with “None known” – but never leave it blank.

• The entry is made as free text, so it should be worded precisely but concisely.

Question: I would like to know the best way to correct or change a Basic UDI-DI in EUDAMED. I tried to create a new entry with a different Basic UDI-DI for a previously registered device. However, I receive an error message (Step 3: UDI-DI identification information) because the UDI-DI code/GTIN of the device has already been used for my previous entry.

The Basic UDI-DI is the primary identifier of a device group (e.g. same intended purpose, risk class, essential design).
It is permanently linked to the device UDI-DI (GTIN) and cannot simply be replaced after submission if an entry with this GTIN already exists.
🔒 Why does the error message appear?

If you try to register a device with a new Basic UDI-DI but use a UDI-DI (GTIN) that has already been submitted under another Basic UDI-DI, EUDAMED identifies this as an inconsistency and blocks the process:

Error: The UDI-DI code has already been used for another Basic UDI-DI.

Possible solutions:

1. Update the existing entry, do not submit a new one

If the UDI-DI/GTIN is already registered, you can only proceed by changing the existing entry – for example through an Update Submission (via web interface or M2M/XML), not by creating a new registration.

👉 But note: The Basic UDI-DI itself cannot be changed for an existing device.

2. If the Basic UDI-DI was genuinely incorrect (e.g. a typo)

Then there are only two options:

• Deactivate/Delete the device and register it again with the correct Basic UDI-DI and UDI-DI

• Or (if the device has not yet been actively marketed): generate a new UDI-DI (new GTIN) and register it again with the correct Basic UDI-DI

📌 Important: The link UDI-DI ↔ Basic UDI-DI is permanent. There cannot be the same GTIN with two different Basic UDI-DIs.

3. If several similar devices are to be registered:

Then each should receive its own GTIN – even if they differ only in certain details – and be registered under separate Basic UDI-DIs where justified (different intended purpose, risk class, etc.).

Question: Could you please describe what correct information should be entered in the ‘Device Model’ field (Step 1: Basic UDI-DI information)? I have noticed that manufacturers do not use this field consistently in EUDAMED.

Definition according to MDCG 2018-1:
The device model (“Device Model”) describes the technical or commercial designation under which the medical device can be identified when marketed or used. It helps distinguish devices within a Basic UDI-DI group.
✅ Correct entries would therefore be:

• A technical model designation stated on the label, in the instructions for use or in the device documentation.

• Or an article-number-based designation if no model number exists.

❌ Not suitable are:

• Device descriptions (“Sterile single-use catheter set for children”)

• Intended purposes (“For the treatment of XYZ”)

• Free text containing keywords or combinations of variants

🔍 Examples of correct device model entries:

Device type	Device model
Pacemaker	Model ACURA 3000
Single-use surgical mask	Type 2R – MaskCare Blue
Dental implant	IMPL-24-Titanium
Software (SaMD)	Diagware v1.4.2
Blood pressure monitor	BP-Monitor Pro M120

Question: Which data elements are mandatory for device registration?

Mandatory fields for device registration in EUDAMED (UDI-DI level)
Organised by category below:

📘 A. Basic Device Information (Step 1 in the GUI)

Field	Mandatory?	Comment
Basic UDI-DI	✅ Yes	Assigned by the manufacturer itself (e.g. via GS1)
Device Name	✅ Yes	Technical name (not marketing text)
Brand Name	❌ No	Only if used on the market
EMDN Code	✅ Yes	EU nomenclature code (at least 4 digits)
Regulatory Status (MDR/IVDR)	✅ Yes	Indicates whether MDR or IVDR applies
Risk Class	✅ Yes	I, IIa, IIb, III (MDR) or A–D (IVDR)
Intended Purpose	✅ Yes	Intended purpose in plain text
Notified Body Information	✅ Yes, if applicable	Only for devices with an NB certificate

📦 B. UDI-DI & Packaging (Step 2 in the GUI)

Field	Mandatory?	Comment
UDI-DI (GTIN or similar)	✅ Yes	Primary identifier on the packaging
Primary Packaging Type	✅ Yes	E.g. individual package, bulk, etc.
Sterility Information	✅ If the device is sterile	Otherwise it may be left blank
Storage & Shelf Life	❌ Optional	Only where temperature/shelf-life dependent
Critical Warnings / Contraindications	❌ Optional	Enter if applicable

👥 C. Economic Operators (Step 3 in the GUI)

Field	Mandatory?	Comment
Manufacturer (SRN)	✅ Yes	Automatic if you are the manufacturer yourself
Authorised Representative	✅ If you are a non-EU manufacturer	Must have a valid SRN
importer	❌ Optional	Only if applicable – otherwise leave blank

🌍 D. Market Information (Step 4 in the GUI)

Field	Mandatory?	Comment
“From” date (Date from)	✅ Yes	Start date of market availability
“To” date (Date to)	❌ No	Only in the event of discontinuation/market withdrawal

📎 E. Attachments (Step 5 in the GUI)

Field	Mandatory?	Comment
Label / IFU Upload	❌ Optional	May be requested during audits, but is not mandatory
Technical documentation	❌ Not directly in EUDAMED	Only required upon request by an authority

Question: Please clarify the “Market Information” section in EUDAMED, in particular the date fields “from (YYYY-MM-DD)” and “to (YYYY-MM-DD)”. What exactly do these dates mean and do they have to be completed?

This depends on the legislation under which you register your device. If you select the legacy legislation (MDD, IVDD, AIMDD), you must enter at least the “valid until” date (you may optionally also enter the start date). However, only the “to” date is mandatory. If, on the other hand, you select a new regulation such as the MDR or IVDR, you do not have to enter a date.

What do the “from (YYYY-MM-DD)” and “to (YYYY-MM-DD)” fields in the “Market Information” section mean?

Field	Meaning
“from” date (Date from which the device is/was made available on the market)	The date from which the device was first made available on an EU market (pursuant to Article 2(27) MDR/IVDR: “making available on the market”)
“to” date (Date until which the device is/was made available on the market)	The date until which the device is or was actively on the market – e.g. in the event of market withdrawal, discontinuation or deactivation

🧠 What does this mean in practice?

• The “from” date is typically the launch date in the EU

• The “to” date is only entered when the device is no longer actively marketed or has a fixed end date

📌 Example:
A device was placed on the market on 01/01/2023 and is still available:
→ “from” = 2023-01-01
→ “to” = leave blank (not required)

⚠️ Are the fields mandatory?

▶️ Current status according to the European Commission (XSD v2.0 & GUI specification):

Field	Mandatory field?
“from” date	✅ Yes, mandatory
“to” date	❌ No, only in the event of discontinuation or market end required

Question: Section 2, “List of all countries where the device is or will be available”: does this apply only to EU countries?

Yes, only EU countries can be selected in this section.

Question: There is a requirement to define one country as “originally placed on the market”. What exactly does this mean? Is it the country in which the medical device (UDI dataset) was first placed on the market?
Does this refer exclusively to the first EU Member State, or can third countries outside the EU also be considered in this field?

EUDAMED relates exclusively to the EU market. Countries outside the EU are not part of this system. Manufacturers wishing to distribute their devices in non-EU countries must separately comply with the respective regulatory requirements of those countries.

Question: Is it advisable to group and register devices by Basic UDI-DI (clustered or separately), e.g. tubing for insufflators? In other words: can devices be grouped to minimise the workload?

Yes, meaningful grouping (“clustering”) of devices under a common Basic UDI-DI is not only permitted but expressly foreseen, provided certain criteria are met. This significantly reduces the registration and maintenance workload in EUDAMED.

📘 What is the Basic UDI-DI and what is it used for?

The Basic UDI-DI is:

• the primary key for the device group

• the link to the declaration of conformity, certification and technical documentation

• not printed on the packaging, but used only in EUDAMED & documentation

📦 When may devices be grouped under one common Basic UDI-DI?

According to MDCG 2018-1 (and the European Commission):

✅ The devices must:

Criterion	Meaning
Same intended purpose	They fulfil the same clinical or diagnostic purpose
Same risk class	e.g. all Class IIa
Similar basic construction / design	e.g. tubing made from the same material with the same connector
Part of the same technical documentation	They are assessed in one file, e.g. together in one DoC

🧪 Example: tubing for insufflators

These can be grouped without difficulty provided that:

• they have the same function (e.g. connection between insufflator and patient)

• they differ only in length, colour or packaging unit

• the the same manufacturer produces them and common technical documentation is available

👉 It is then advisable to cluster these variants under one Basic UDI-DI and multiple UDI-DIs (GTINs) and register them under this Basic UDI-DI.

🎯 Advantages of clustering (grouping):

Advantage	Description
🔁 Less effort	Only one registration at Basic level with multiple UDI-DIs
🧾 Consistent documentation	Only one declaration of conformity & technical file required
🔍 Better overview	In EUDAMED you can manage your variants in a more structured way
📈 Scalability	New variants can be added more easily later

⚠️ But note: when you should not cluster:

Do not cluster if…	Reason
Different intended purpose	e.g. tubing for CO₂ vs. other gases
Different risk classes	e.g. Class I vs. Class IIa
Different regulatory assessments	e.g. one variant is sterile and the other is not
Different certificates or Notified Bodies	→ separate Basic UDI-DIs required

Question: May we use Basic UDI-DIs generated by GS1 for Legacy Devices, or do we have to have them generated by EUDAMED? Does this mean the latter have to be linked to the new ones?

Yes, you may also use GS1-generated Basic UDI-DIs for Legacy Devices – automatic generation by EUDAMED is not required.
👉 You must assign the Basic UDI-DI yourself (e.g. via GS1) – also for Legacy Devices – if you want to register them in EUDAMED (voluntarily or later when mandatory).

Question: Is there a way to generate new EMDN codes if a new device based on new technology cannot be matched to any of the existing codes?

No, manufacturers cannot generate their own EMDN codes. New codes can only be added by the European Commission – upon request or through defined channels.
What should you do if there is no suitable EMDN code?

Go through the closest select the EMDN code

• You are required to select the best-matching existing code

• If, for example, your device is an innovative portable dialysis device but only codes for conventional dialysis machines exist, choose the closest match

• As a rule, 4-digit or 6-digit codes (Level 2 or 3) are sufficient for device registration

📌 This selection must be well documented – including for audits (e.g. why you selected this code).

Question: What else can be done with the GUI, for example can you search for specific devices, device classes, manufacturers, importers, etc.? The search often returns no results.

Typical functions in the UDI/Device module:

Function	Description	Note
🔍 Search for devices	By UDI-DI (GTIN), Basic UDI-DI, Device Name, Brand Name	Often case-sensitive and very restrictive
🗂️ View device details	All details of the registered device incl. packaging, label, Intended Use, etc.	Only if the search returns the correct result
✏️ Change device (Update Submission)	Change or add device information	Only for devices associated with your own SRN
🗑️ Deactivate device	Remove or withdraw device from the market	Possible only for the registering manufacturer
⬆️ Register a new device	Using the complete 5-step wizard	Basic UDI-DI must be correct
⏳ Check device status	“Submitted”, “Under Review”, “Published”, etc.	Important overview of workflow status

Typical functions in the Actor module:

Function	Description	Note
🔍 Search for actors	By SRN, company name, role (manufacturer, importer, etc.)	Often works only with the exact spelling
🔗 Linking to other actors	e.g. manufacturer with importer or Authorised Representative	The link is created by the importer in the Actor module
🧾 View actor details	Address, roles, responsibilities, etc.	Useful for authorities or supply-chain evidence

⚠️ Why does the search often return no results?
Here are the most common causes and tips:
1. Incorrect spelling / incorrect formatting

• EUDAMED distinguishes between upper and lower case
  🔍 Acura3000 ≠ acura3000

2. Partial terms do not work

• No automatic “contains” search → e.g. Medi does not MediPlus 5000
  👉 If possible, use the full name

3. SRN entered incorrectly

• SRNs must be entered in the exact format (e.g. DE-MF-000000xxx)

4. No access to third-party entries

• You can see only devices/actors that are linked to your organisation
  👉 Publicly visible data will become available only once EUDAMED is fully live

5. Outdated/expired sessions

• The GUI has a timeout, after which actual results may no longer be displayed – it often helps to log in again
  Tips for a successful search in the GUI:

  What you are looking for	How to enter it
  UDI-DI / GTIN	Enter the complete number exactly
  Basic UDI-DI	Without spaces or special characters
  Device name / model	Exactly as in the EUDAMED entry
  Manufacturer / Importer (SRN)	Complete with country code (DE-MF-...)
  Status	Optional: search only for active devices (Published)

Question: Is there an Excel upload? How can we avoid duplicate data maintenance in EUDAMED and internally?

EUDAMED itself does not offer direct Excel upload as a submission format. Structured exchange methods provided by EUDAMED are used for technical data transmission.
You can nevertheless maintain your UDI data in Excel and build a controlled transmission process from it:

• Structured Excel data entry: Maintain UDI data in a central template instead of manually entering the same information several times.
• Validation before submission: Check mandatory fields, formats and regulatory rules before transmission.
• Transmission and status: The Global Submission Portal processes the data for submission and displays the status of submissions in a transparent way.

→ View the EUDAMED Excel template
→ View the Global Submission Portal

Question: Which solution is suitable for our EUDAMED device registration?

The appropriate solution mainly depends on where your UDI master data is currently maintained and how many records you need to manage on a regular basis.

Current situation	Suitable approach
Individual or only a few records	Direct maintenance via the EUDAMED GUI may be sufficient.
UDI data is available in Excel or a non-SAP system	Global Submission Portal: structured import, validation, submission and status tracking.
UDI master data is maintained in SAP	SAP UDI Add-On: manage UDI data directly in SAP and make it available for EUDAMED.
EUDAMED data is also to be used in swissdamed	EUDAMED → swissdamed synchronisation: reuse existing data in a structured way.

Not sure which approach makes sense? Briefly tell us your data source and the number of your UDI-DIs.

Question: Will EUDAMED replace registration in local databases once the modules are mandatory?

Not across the board. Since 28 May 2026 use of the first four EUDAMED modules has been mandatory. This includes the UDI/Devices module. EUDAMED is therefore the central system for these EU-wide processes.
However, this does not automatically mean that every national registration, notification or other market requirement ceases to apply. Member States may continue to impose national obligations for certain matters, for example in connection with national market surveillance, Legacy Devices, vigilance, fees or other country-specific requirements.

Area	Practice since 28 May 2026
UDI/Device registration	EUDAMED is the relevant system for mandatory EU registration.
Actor registration	The Actor module is one of the mandatory EUDAMED modules.
National obligations	Additional national requirements must still be checked for each target market.

Practical tip: EUDAMED and national market requirements should be treated as two separate review steps. EUDAMED registration alone does not automatically demonstrate that all national requirements have been met.

Question: Which local databases or national requirements must still be considered in addition to EUDAMED?

A blanket list that remains permanently valid is problematic here. National registration and notification requirements can change and depend, among other things, on the Member State, device type, regulatory status, economic operator role and specific distribution model.
For manufacturers and other economic operators, this means that after EUDAMED registration, each target country should be checked separately to determine whether additional national portals, notifications, fees or other requirements apply.

Target country	Competent authority / point to check
Germany	BfArM / DMIDS – check the current national obligations for the specific case
France	ANSM – check additional national requirements
Italy	Ministero della Salute – check current national registration requirements
Spain	AEMPS – check current national requirements
Belgium	FAMHP / AFMPS – check current national requirements
Austria	BASG – check current national requirements

Important: This overview deliberately identifies only the competent authorities/checkpoints and does not claim that an additional device registration is mandatory for every device in every country listed. The specific obligation must be checked on a case-by-case basis against the current requirements.