FAQ on EUDAMED and UDI. In our webinars on EUDAMED and UDI, we receive many questions about legacy devices, the M2M interface, XML bulk upload, timelines, and responsibilities. We have collected these questions and answered the most common ones for you in this EUDAMED and UDI compliance Q&A.

Over the past months, we hosted four webinars with more than 1,000 total registrations. Companies from Switzerland, China, Thailand, Spain, and other countries were able to get a clear overview of their upcoming UDI project. The topic has gained urgency because of the approaching deadlines on May 28 and November 28 this year.

During the webinars, participants could also submit their questions – an offer that was used extensively. Many medical device manufacturers are still unsure which deadline applies to their specific situation. Others are currently deciding how they want to upload their UDIs into EUDAMED and are comparing XML bulk upload with the M2M interface. Others again wanted to clarify their responsibilities as importers, non‑EU manufacturers, or Authorized Representatives.

1. UDI‑DI & Basic UDI‑DI – Rules, Packaging, Product Variants

Q1: Do all packaging levels of an MDR product need to be registered in EUDAMED?
You must indicate the packaging levels in which a product is placed on the market.

Q2: When must a new UDI‑DI be assigned for an already registered product?
The detailed definition is found in MDR Annex VI, Part C, 3.9.
A new UDI‑DI is required whenever the existing one could lead to product misidentification or issues with traceability. This includes changes to:

• Name or trade name
• Product version or model
• Sterile packaging
• Single‑use devices
• Devices requiring sterilization before use
• Number of units in a package
• Warnings or contraindications

Q3: Do sterile and non‑sterile variants of the same device need separate registrations?
Yes. Otherwise, the variants could be confused. See Q2.

Q4: How do I handle multiple trade names, EANs or article numbers for the same device?
If the trade name, model, or EAN varies, product identity is no longer clear, a new UDI‑DI must be assigned (see Q2).

Q5: Can product groups be registered instead of individual products?
Product groups or product families are assigned a Basic UDI‑DI.
A product family may be, for example, one product model available in various versions.
The Basic UDI‑DI links key regulatory information such as certificates, declarations of conformity and technical documentation.

2. Deadlines, Transitional Rules & Classifications under MDR/IVDR

Q6: What transitional deadlines apply for MDR and legacy devices until the end of 2026?

Products placed on the EU market before 28 May 2026 must be registered by 28 November 2026.

Products placed on the market after 28 May 2026 must be registered before being placed on the market.

Q7: Does the UDI‑DI need to change if an IVDD product is later certified under IVDR?
Both devices require a UDI.
You may reuse the same UDI‑DI if it is exactly the same product with the same characteristics.
The IVDR product must always be registered.
If the IVDR version is registered first (and within the timelines), the IVDD version no longer needs registration.

Q8: What if the device class changes (e.g., Class I → IIa) during the transition?
Both the Class I and the Class IIa versions require certificates, which must be linked accordingly. Both must be registered.

Q9: Does the 12‑month rule apply to both MDR‑compliant and legacy devices?
Only the date of placing on the market determines the deadline.

Q10: What does “placing on the market” mean in connection with MDR/EUDAMED deadlines?
Definition from the MDR: “‘making available on the market’ means any supply of a device, other than an investigational device, for distribution, consumption or use on the Union market in the course of a commercial activity, whether in return for payment or free of charge.”

The following do not count as placing on the market:

• supplying devices for clinical investigations

• supplying IVDs for performance studies

• further supply after the device has been put into service (unless refurbished or significantly modified)

This means that in these cases, a product will not be placed on the market (again).

Example:
A device stored at the manufacturer is not placed on the market. Once it is handed over to a distributor for the first time, it is considered placed on the market. All subsequent units are also considered placed on the market.

3. Registration Responsibilities – Who Must Register What in EUDAMED?

Q11: Must the manufacturer, importer or Authorized Representative register the UDI?
The manufacturer is responsible.
Importers and Authorized Representatives must check compliance.
The manufacturer may delegate the task, but not the responsibility.

Q12: Must products be registered in EUDAMED if they are not sold in the EU?
Products that are not placed on the market in the EU do not need to be registered in EUDAMED. The registration requirement only applies to products that are placed on the market in the EU for the first time (MDR/IVDR devices or legacy devices, depending on their status). There may be cases where registration is still necessary. In such cases, the definition of ‘placed on the market’ is particularly important.
However, regulations still stipulate that also products with the following status could be registered:

• “not intended for the EU market”
• “no longer placed on the EU market”

Reasons may include: Medical device manufacturers have their products certified according to MDR/IVDR, even if they are not (yet) sold on the European market. They do this, for example, to prepare for future market entries, to increase global acceptance (MDR/IVDR is an international quality feature), to demonstrate regulatory readiness, and to harmonise manufacturer portfolios. Manufacturers are also increasingly using EUDAMED as a master data hub to store all their master data in one place.

Q13: Does batch/lot information need to be provided?

No, only general product data needs to be entered, not specific data for each medical device produced. This means that all data relating to the UDI-DI (Device Identifier) is stored in EUDAMED. All UDI-PI data (Production Identifier) is made accessible via the label.

Q14: Must inactive or discontinued UDI‑DIs be registered?
If products are still on the market, yes.
They can be marked as “no longer placed on the market”.

4. GS1, HIBC & Technical Validation

Q15: Must the GS1 UDI‑DI be registered including the check digit?
Yes.

Q16: How should HIBC UDI‑DIs be submitted? With or without a check character?
If the check character is printed on the label, it should also be included in EUDAMED.

Q17: How are UDI data validated before upload?
There is no pre-validation for manual entries in EUDAMED. If an error is detected, the product cannot be registered. In the mytracekey UDI Manager software, the data is checked against the EUDAMED business rules during import, and explanations of the errors detected are provided. This saves manufacturers from having to search for errors and make revisions during registration.

5. EUDAMED Platform – Access, Visibility, Usage

Q18: Where can I find the EUDAMED playground for the UDI module?

Playground: https://webgate.training.ec.europa.eu/eudamed-play/landing-page
Productive System: https://webgate.ec.europa.eu/eudamed/landing-page

The EUDAMED Playground is designed to test the entry of UDI data, enter dummy data and set up the M2M interface. Data entered here is not transferred to the EUDAMED production system and may contain errors. Manufacturers should therefore always take their first steps in the EUDAMED Playground.

The EUDAMED Productive System is responsible for live data. What is entered here is accessible to other stakeholders and to the public. No test data should be entered here, only fully validated data.

Q19: Can products be registered before receiving the MDR/IVDR certificate?
Yes.
Once the UDI is assigned, registration is possible.
Notified Bodies later link certificates in the Certificates module.

Q20: Must the Basic UDI‑DI be registered before the UDI‑DI?
When you enter data for this Basic UDI-DI for the first time, you must also provide information about a UDI-DI. Basic UDI-DIs can only be entered together with UDI-DI data. If you subsequently register additional UDI-DIs for the already registered Basic UDI-DI, you do not need to re-enter this information.

6. Data Quality, Bulk Upload, M2M & Error Handling

Q21: Where can I find the XML specification for bulk upload?
The XML-Bulk-Upload-Specifications can be found in various documents. They are available in:

• Document sizes and upload specifications: EUDAMED Business Rules Common

• Guidelines for data exchange with EUDAMED: EUDAMED User Guide

• There are also Data Exchange Documents available for download

Q22: Is an M2M connection mandatory?
No. Manual entry or XML bulk upload is always possible.
However, M2M is strongly recommended for larger portfolios.

Q23: Which data must be prepared before upload?
All UDI data, device master data, and the correct Basic UDI‑DIs. Exact requirements depend on the product. The EUDAMED Business Rules list all required information.
Alternatively, you can use our ‘mytracekey UDI Manager’ solution to quickly and easily find out what data is required for your products.

Q24: Can incorrect UDI‑DIs be corrected later?
Once entered in the productive system, most fields cannot be changed.
Therefore, pre‑validation and playground testing are essential.

Q25: How can I ensure that my data is validated correctly?
By using a validation tool such as the UDI Manager or by manually checking all data against the EUDAMED Business Rules.

7. Cross‑Market Use & Swissdamed

Q26: Can a UDI registered in EUDAMED also be used in Australia?
Australia’s Therapeutic Goods Administration (TGA) has clearly based its UDI system on the international IMDRF model. This includes:

• UDI consists of UDI DI + UDI PI,
• UDI is assigned by internationally recognised issuing agencies,
• Harmonisation with international standards is explicitly sought.

AusUDID does not require national UDI codes. Under these circumstances, the UDI itself can be the same. However, the product master data that must be entered in EUDAMED and AusUDID differs. For example, there is no Basic UDI-DI in the Australian UDI system.

Q27: Who is responsible if the product is manufactured in Canada or China but imported into the EU?
The manufacturer is responsible for entering the UDI data. The task itself can be delegated to third parties, such as the Authorised Representative (AR). To do this, however, the manufacturer must grant access to their EUDAMED account. Direct entry via the AR is not provided for in the role and authorisation concept.

Q28: Does Swissdamed allow manual upload?
No. Swissdamed currently supports only XML bulk upload.

Q29: Is the Swissdamed feature included in the tracekey UDI Manager license?
Yes. A Swissdamed module is included free of charge for UDI Manager customers.

8. UDI Software & Tools – Data Export, Validation, Partner Use

Q30: What happens to my EUDAMED data if I cancel the mytracekey software?
Your data and tenant are deleted from the software.
Data already stored in EUDAMED remains in the EU database.

Q31: Can data entered in the software be exported for use in other systems?
Depending on your subscription, an export function is available.

Q32: Does the software support HIBCC entry according to EUDAMED format (with “+”)?
Yes. The UDI Manager fully supports HIBCC and GS1 formats.

Q33: Is there a one‑time upload tool without ongoing license costs?
Our mytracekey UDI Manager software is designed as a long-term solution. That is why we offer cloud-based software on a subscription basis with an annual term. This allows you to relax and carry out the initial upload, have an audit-ready UDI process on hand, benefit from software updates and enhancements, and have a secure process for versioning data when changes are made.

Frequently Searched Terms and Definitions

UDI‑DI
The static, unique identifier for a device version.
Changes only when key device or labeling characteristics change.

Basic UDI‑DI
Groups several UDI‑DIs of a product family.
Used for regulatory processes and not printed on the label.

EUDAMED Registration
Includes:

1. Economic Operator registration → receive SRN
2. UDI/Device registration → upload device & UDI data

Legacy Devices
Devices previously marketed under MDD/AIMDD/IVDD and still sold during the MDR/IVDR transition.

MDR Transitional Periods
Allow continued marketing of devices with legacy certificates under conditions (valid certificate, no significant changes, QMS in place).

GS1 vs. HIBC
Both are MDR/IVDR‑compliant UDI issuing agencies.
GS1 uses GTINs; HIBC offers more flexibility but is used more regionally.

EUDAMED XML Upload
Bulk upload method using EU XSD‑compliant XML files.

EUDAMED Error Codes
Technical or business rule violations detected during XML or M2M submission.

Swissdamed
Swiss UDI and device database based on EUDAMED standards, operated by Swissmedic.

OBL (Own Brand Labelling)
Brand owners selling devices manufactured by another company become full legal manufacturers under MDR.

 

[Disclaimer]

The information provided here is only one possible interpretation of the regulations. These are also subject to constant change, so the information in this article may be incomplete or no longer up to date. The above article is expressly not intended as legal advice. Please consult the official documents before making any business decisions. (Information status: January 2026)