FAQEU

EU MDR FAQ UDI-DI and Basic UDI-DI

Basic UDI-DI and UDI-DI are related but different identifiers in the EU MDR UDI system.

Use this FAQ to distinguish the model-level Basic UDI-DI from UDI-DI records used for device, packaging, label, UDI carrier, and EUDAMED data.

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Author
Sorena AI
Published
May 9, 2026
Updated
May 9, 2026
Questions
4

Structured answer sets in this page tree.

Primary sources
2

Cited legal and guidance references.

Publication metadata
Sorena AI
Published May 9, 2026
Updated May 9, 2026
Overview

Under the EU MDR, the Basic UDI-DI is the main model-level key for the UDI database and regulatory documents, while the UDI-DI is the device or packaging-level identifier that gives access to UDI database information. Assign and maintain both through the manufacturer's UDI process, keep the UDI carrier and EUDAMED data aligned, and issue a new UDI-DI when a change could cause misidentification or traceability ambiguity.

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4 of 4 questions
Question 1

How should Basic UDI-DI and UDI-DI be assigned under the EU MDR?

Assign the Basic UDI-DI at the device model grouping level. It is the main key for records in the UDI database and is referenced in documents such as product certificates, EU declarations of conformity, technical documentation, and, where relevant, SSCP or PSUR materials.

Assign the UDI-DI at the device and packaging level. It is specific to a manufacturer and device model, is unique at each level of device packaging, and works with the UDI-PI to form the UDI conveyed by the UDI carrier.

  • Use the Basic UDI-DI to connect devices with the same intended purpose, risk class, and essential design and manufacturing characteristics.
  • Use UDI-DIs for the device and higher packaging levels; shipping containers are not higher levels of packaging for this purpose.
  • For devices needing notified-body product certificates, align the Basic UDI-DI grouping with the notified body so certificates and supporting regulatory documents reference the right grouping.
Citations
MDCG 2022-7 - UDI system Q&A

Explains UDI-DI, Basic UDI-DI grouping, package-level UDI-DIs, and when Basic UDI-DIs appear in regulatory documentation.

Question 2

How do UDI carriers, labels, and EUDAMED records fit together?

The UDI carrier is the label or device marking mechanism that conveys the UDI, normally through AIDC and, where applicable, human-readable interpretation. It is an additional UDI requirement and does not supersede other MDR labelling requirements.

EUDAMED is the registration destination for UDI/device information. The Commission UDI/device registration page states that manufacturers must submit UDI/device information in EUDAMED for devices they place on the EU market and points to data sets covering MDR UDI and device data.

  • Keep the label artwork, package hierarchy, and UDI carrier specification traceable to the assigned UDI-DI and UDI-PI.
  • Confirm that UDI/device data submitted to EUDAMED matches the Basic UDI-DI, UDI-DI, packaging level, manufacturer, EMDN, and device characteristics used in regulatory records.
  • Do not treat the presence of a UDI-DI in the UDI database as proof of MDR conformity; it is an identifier record, not a conformity decision.
Citations
Question 3

When do changes trigger a new UDI-DI?

A new UDI-DI is required when a change could lead to misidentification of the device or ambiguity in traceability. MDCG 2022-7 repeats the MDR Annex VI examples and gives practical examples for package quantity and substance-based devices.

The clearest triggers include changes to the name or trade name, device version or model, single-use status, sterile packaging status, need for sterilisation before use, package quantity, or critical warnings and contraindications such as latex or DEHP.

  • A package quantity change, such as moving from 5 to 10 devices in a package, requires a new UDI-DI for that package because it can create traceability ambiguity.
  • For substance-based medical devices, a formulation quantity change or additional medical-purpose claim can require a new UDI-DI when it creates misidentification or traceability risk.
  • If a single-use device is reprocessed by a person who becomes the manufacturer under MDR Article 17(2), MDCG 2022-7 says the reprocessed device needs a new Basic UDI-DI and UDI.
Citations
MDCG 2022-7 - UDI system Q&A

Lists UDI-DI change triggers and gives examples for package quantity changes, substance-based devices, and reprocessed single-use devices.

Question 4

What records should be retained?

Keep a record that links the identifier to the product facts that justified it. The useful record is not just the code; it is the grouping rationale, issuing entity rule, packaging level, label or carrier evidence, EUDAMED submission data, and any change assessment that explains why the identifier stayed the same or changed.

For reprocessing and relabelling situations, keep traceability back to the original device identifier where the guidance or MDR rule calls for it. MDCG 2022-7 says a reprocessor who becomes the manufacturer should keep the original product UDI in technical documentation and the QMS, and MDR Annex VI requires manufacturers that relabel or repackage devices with their own label to retain the original manufacturer's UDI.

  • Retain the Basic UDI-DI grouping rationale, including intended purpose, risk class, and essential design or manufacturing characteristics.
  • Retain UDI-DI records for the device and packaging levels, plus the UDI-PI rules used for lot, serial, software, manufacturing, or expiry data on the label.
  • Retain EUDAMED submission confirmations or exported records, label artwork, UDI carrier scans or proofs, notified-body alignment where relevant, and change assessments for each new or unchanged UDI-DI decision.
Citations
MDCG 2022-7 - UDI system Q&A

Supports retention of original product UDI for reprocessed devices and explains traceability expectations for supplied devices.

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Review UDI-DI and Basic UDI-DI records

Check whether model grouping, device and package identifiers, label carriers, EUDAMED data, and change records tell the same traceability story.

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Primary sources

References and citations

MDCG 2022-7 - UDI system Q&A
health.ec.europa.eu
Referenced sections
  • Supports retention of original product UDI for reprocessed devices and explains traceability expectations for supplied devices.
"keep the UDI of the original product"
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