---
title: "How should Basic UDI-DI and UDI-DI be assigned under the EU MDR?"
canonical_url: "https://www.sorena.io/artifacts/eu/medical-device-regulation/faq/udi-di-and-basic-udi-di"
source_url: "https://www.sorena.io/artifacts/eu/medical-device-regulation/faq/udi-di-and-basic-udi-di"
author: "Sorena AI"
description: "EU MDR FAQ explaining what Basic UDI-DI and UDI-DI identify, how they connect to UDI carriers, EUDAMED records, change triggers, and retained evidence."
published_at: "2026-05-09"
updated_at: "2026-05-09"
keywords:
  - "EU Medical Device Regulation"
  - "EU MDR"
  - "Basic UDI-DI"
  - "UDI-DI"
  - "UDI carrier"
  - "EUDAMED"
  - "UDI-DI and Basic UDI-DI"
  - "EU MDR FAQ"
---
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---

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

EU MDR FAQ explaining what Basic UDI-DI and UDI-DI identify, how they connect to UDI carriers, EUDAMED records, change triggers, and retained evidence.

*FAQ* *EU*

## 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.

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.

## 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.

Sources for this answer:

- [MDCG 2022-7 - UDI system Q&A](https://health.ec.europa.eu/system/files/2022-05/mdcg_2022-7_en.pdf?ref=sorena.io) - Explains UDI-DI, Basic UDI-DI grouping, package-level UDI-DIs, and when Basic UDI-DIs appear in regulatory documentation.

## 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.

Sources for this answer:

- [MDCG 2022-7 - UDI system Q&A](https://health.ec.europa.eu/system/files/2022-05/mdcg_2022-7_en.pdf?ref=sorena.io) - Supports the distinction between UDI-DI, UDI-PI, UDI carrier placement, package levels, and UDI database data.
- [European Commission - EUDAMED UDI/device registration](https://health.ec.europa.eu/medical-devices-eudamed/udidevice-registration_en?ref=sorena.io) - Commission page stating that manufacturers submit UDI/device information in EUDAMED and identifying MDR UDI/device data sets.

## 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.

Sources for this answer:

- [MDCG 2022-7 - UDI system Q&A](https://health.ec.europa.eu/system/files/2022-05/mdcg_2022-7_en.pdf?ref=sorena.io) - Lists UDI-DI change triggers and gives examples for package quantity changes, substance-based devices, and reprocessed single-use devices.

## 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.

Sources for this answer:

- [MDCG 2022-7 - UDI system Q&A](https://health.ec.europa.eu/system/files/2022-05/mdcg_2022-7_en.pdf?ref=sorena.io) - Supports retention of original product UDI for reprocessed devices and explains traceability expectations for supplied devices.
- [European Commission - EUDAMED UDI/device registration](https://health.ec.europa.eu/medical-devices-eudamed/udidevice-registration_en?ref=sorena.io) - Supports retaining EUDAMED UDI/device registration evidence and EMDN registration context.

## Primary sources

- [MDCG 2022-7 - UDI system Q&A](https://health.ec.europa.eu/system/files/2022-05/mdcg_2022-7_en.pdf?ref=sorena.io) - UDI-specific guidance used for UDI-DI and Basic UDI-DI meaning, assignment logic, change triggers, carrier placement, and retained traceability records.
  - Quote: "Questions and answers on the Unique Device Identification system"
- [European Commission - EUDAMED UDI/device registration](https://health.ec.europa.eu/medical-devices-eudamed/udidevice-registration_en?ref=sorena.io) - Commission page used for EUDAMED UDI/device registration, data-set, helpdesk, and EMDN context.
  - Quote: "UDI/Device registration"

## Topic Guides

- [Custom-made medical devices under the EU MDR | EU MDR FAQ](/artifacts/eu/medical-device-regulation/faq/custom-made-devices.md): Concise EU MDR FAQ on custom-made device definition, mass-produced exclusions, Annex XIII statements, documentation, conformity assessment, PMS, vigilance, and records to retain.
- [EU MDR Annex II and III Technical Documentation](/artifacts/eu/medical-device-regulation/annex-ii-and-iii-technical-documents.md): Build an MDR technical documentation index for Annex II device files and Annex III post-market surveillance evidence, including GSPR, risk, clinical, PMS, UDI, and EUDAMED records.
- [EU MDR Annex VIII Classification Guide](/artifacts/eu/medical-device-regulation/annex-viii-classification.md): Classify EU MDR medical devices under Annex VIII using intended purpose, duration, invasiveness, active device and software rules, and conformity assessment impact.
- [EU MDR Annex XVI products without a medical purpose](/artifacts/eu/medical-device-regulation/annex-xvi-products.md): source-linked EU MDR guide for Annex XVI products: listed product groups, common specifications, clinical evidence, notified-body route, UDI, EUDAMED, PMS, and vigilance evidence before launch.
- [EU MDR Applicability Test](/artifacts/eu/medical-device-regulation/applicability-test.md): Test whether a product, accessory, software function, or Annex XVI product falls under the EU Medical Device Regulation, and record the evidence for the next classification step.
- [EU MDR change assessment workflow](/artifacts/eu/medical-device-regulation/change-assessment-workflow.md): Assess EU MDR device, design, software, intended purpose, QMS, clinical, PMS, UDI, classification, and notified-body impacts before releasing a medical device change.
- [EU MDR Checklist for Medical Device Compliance](/artifacts/eu/medical-device-regulation/checklist.md): Practical EU MDR checklist covering qualification, classification, conformity assessment, technical documentation, GSPR, clinical evidence, UDI, EUDAMED, PMS, vigilance, QMS, and legacy transition evidence.
- [EU MDR classification workflow](/artifacts/eu/medical-device-regulation/classification-workflow.md): A concrete EU MDR classification workflow for intended purpose, device or accessory qualification, Annex VIII rule selection, Rule 11 software review, class outcome, and notified body impact.
- [EU MDR Clinical Evaluation Overview](/artifacts/eu/medical-device-regulation/clinical-evaluation-overview.md): EU MDR clinical evaluation overview covering Article 61, Annex XIV, clinical data sources, equivalence, PMCF, CER evidence, notified body review, GSPR, and benefit-risk support.
- [EU MDR Clinical Evaluation Report Template](/artifacts/eu/medical-device-regulation/clinical-evaluation-report-template.md): A source-linked EU MDR clinical evaluation report template covering intended purpose, GSPR linkage, clinical data appraisal, equivalence limits, PMCF, conclusions, and reviewer signoff.
- [EU MDR clinical evidence guide](/artifacts/eu/medical-device-regulation/clinical-evidence.md): source-linked EU MDR guide to clinical evaluation, clinical investigations, equivalence, PMCF, GSPR support, technical documentation, and notified-body review.
- [EU MDR compliance obligations](/artifacts/eu/medical-device-regulation/compliance.md): EU MDR compliance guide for device qualification, classification, conformity assessment, QMS, technical documentation, UDI, EUDAMED, PMS, vigilance, and legacy transition controls.
- [EU MDR conformity route workflow](/artifacts/eu/medical-device-regulation/conformity-route-workflow.md): source-linked EU MDR workflow for classifying a device, choosing the conformity assessment route, preparing technical and QMS evidence, and reaching certificate, DoC, UDI, EUDAMED, and CE outputs.
- [EU MDR deadlines and compliance calendar](/artifacts/eu/medical-device-regulation/deadlines-and-compliance-calendar.md): Grounded EU MDR calendar for application, legacy-device transition, UDI, EUDAMED, and recurring QMS, technical documentation, clinical, PMS, vigilance, certificate, and change reviews.
- [EU MDR Device Classification Guide](/artifacts/eu/medical-device-regulation/device-classification-guide.md): Classify an EU MDR medical device by intended purpose, Annex VIII duration, invasiveness, active-device and software rules, then document the conformity route impact.
- [EU MDR EUDAMED and UDI registration](/artifacts/eu/medical-device-regulation/eudamed-and-udi.md): source-linked MDR guide to Basic UDI-DI, UDI-DI, EUDAMED device registration, actor roles, labels, technical documentation, and UDI data governance.
- [EU MDR FAQ: qualification, evidence, UDI, and transition](/artifacts/eu/medical-device-regulation/faq.md): Concise EU MDR FAQ covering device qualification, software classification, accessories, custom-made devices, clinical evidence, UDI, EUDAMED, notified bodies, significant changes, and legacy transition.
- [EU MDR Legacy Device Transition](/artifacts/eu/medical-device-regulation/legacy-device-transition.md): source-linked EU MDR legacy device transition guide covering Regulation (EU) 2023/607 conditions, certificate validity, significant-change limits, surveillance, PMS, vigilance, QMS, and evidence records.
- [EU MDR notified body route selection](/artifacts/eu/medical-device-regulation/notified-body-route-selection.md): Choose an EU MDR conformity assessment route by device class, Article 52 option, notified body designation scope, QMS readiness, technical documentation, clinical evidence, and certificate evidence.
- [EU MDR penalties and enforcement risk](/artifacts/eu/medical-device-regulation/penalties-and-fines.md): source-linked EU MDR penalties and enforcement-risk guide covering Article 113, Member State penalty rules, market restrictions, recalls, certificate consequences, and evidence.
- [EU MDR PMS and Vigilance Guide](/artifacts/eu/medical-device-regulation/pms-and-vigilance.md): EU MDR guide to post-market surveillance, PMCF updates, PMS reports, PSURs, serious incident reporting, FSCA/FSN handling, trend reporting, and evidence records.
- [EU MDR PMS and vigilance records](/artifacts/eu/medical-device-regulation/post-market-surveillance-and-vigilance.md): source-linked EU MDR guide to PMS plans, PMS reports, PSURs, PMCF updates, serious incident and FSCA reporting, trend reporting, and EUDAMED evidence handling.
- [EU MDR PMS Plan Template for Medical Devices](/artifacts/eu/medical-device-regulation/post-market-surveillance-plan-template.md): A source-linked EU MDR post-market surveillance plan template covering device scope, PMS data sources, PMCF linkage, vigilance, trend reporting, PMSR or PSUR outputs, roles, cadence, and evidence records.
- [EU MDR QMS and technical file evidence map](/artifacts/eu/medical-device-regulation/qms-and-technical-file.md): Map EU MDR Article 10 QMS duties to Annex II and Annex III technical documentation, PMS, vigilance, UDI records, and notified-body review evidence.
- [EU MDR QMS requirements under Article 10](/artifacts/eu/medical-device-regulation/qms.md): EU MDR QMS guide for Article 10 manufacturer controls covering regulatory strategy, design, risk, clinical evaluation, PMS, vigilance, UDI, suppliers, CAPA, and conformity records.
- [EU MDR qualification and borderline products](/artifacts/eu/medical-device-regulation/qualification-and-borderline-products.md): EU MDR qualification guide for medical purpose claims, accessories, software, Annex XVI products, and borderline routes to classification and conformity assessment.
- [EU MDR qualification workflow](/artifacts/eu/medical-device-regulation/qualification-workflow.md): A concrete EU MDR workflow for deciding whether a product is a medical device, accessory, Annex XVI product, IVD interface, medicinal-product interface, or non-MDR product before classification and conformity assessment.
- [EU MDR requirements checklist](/artifacts/eu/medical-device-regulation/requirements.md): Concrete EU MDR requirements for medical-device scope, classification, GSPR, conformity assessment, technical documentation, QMS, clinical evidence, UDI, EUDAMED, PMS, vigilance, and economic-operator records.
- [EU MDR Rule 11 software classification](/artifacts/eu/medical-device-regulation/rule-11-software.md): Classify MDR medical device software under Rule 11 using intended purpose, diagnosis or therapy decision impact, physiological monitoring, conformity route, clinical evidence, and software-change records.
- [EU MDR significant changes FAQ: legacy-device transition and notified-body review](/artifacts/eu/medical-device-regulation/faq/significant-changes.md): FAQ on MDR significant changes for legacy devices, including intended-purpose, design, software, material, sterilisation, clinical, QMS, notified-body, and evidence impacts.
- [EU MDR Transition Timelines: practical guide](/artifacts/eu/medical-device-regulation/transition-timelines.md): EU Medical Device Regulation guide to Transition Timelines with scope decisions, owner actions, evidence records, source-linked citations, and practical next steps.
- [EU MDR UDI and EUDAMED registration guide](/artifacts/eu/medical-device-regulation/udi-and-eudamed.md): EU MDR guide to Basic UDI-DI, UDI-DI, UDI carriers, EUDAMED actor and device registration, change impacts, and evidence governance.
- [EU MDR vigilance reporting workflow](/artifacts/eu/medical-device-regulation/vigilance-reporting-workflow.md): Concrete EU MDR vigilance workflow for incident intake, serious incident assessment, FSCA and FSN handling, trend reporting, EUDAMED caveats, CAPA, PMS, clinical evaluation updates, and records.
- [MDR vs AI Act for medical-device software](/artifacts/eu/medical-device-regulation/mdr-vs-ai-act.md): Compare MDR software qualification, classification, clinical evidence, QMS, PMS, UDI, EUDAMED, and notified-body evidence boundaries against cautiously scoped AI Act overlap.
- [MDR vs GPSR: medical-device boundary checks](/artifacts/eu/medical-device-regulation/mdr-vs-gpsr.md): Compare MDR medical-device scope with general product-safety fallback questions for borderline, non-medical, and Annex XVI products.
- [MDR vs IVDR: medical devices and IVDs compared](/artifacts/eu/medical-device-regulation/mdr-vs-ivdr.md): Compare EU MDR and IVDR scope, classification, conformity routes, technical documentation, clinical or performance evidence, UDI, EUDAMED, PMS, and vigilance.
- [MDR vs Product Liability Directive evidence comparison](/artifacts/eu/medical-device-regulation/mdr-vs-product-liability-directive.md): Compare EU MDR market-access evidence with Product Liability Directive exposure without treating compliance records as a liability outcome.
- [What should an EU MDR PMCF plan and report cover? | EU MDR FAQ](/artifacts/eu/medical-device-regulation/faq/pmcf.md): Under the EU MDR, PMCF is part of PMS and clinical evaluation. See what the plan, activities, report, updates, and retained evidence should cover.
- [What should manufacturers do when an EU MDR classification changes? | EU MDR FAQ](/artifacts/eu/medical-device-regulation/faq/class-changes.md): Concise EU MDR FAQ on classification changes, intended purpose, software, notified-body route impact, certificates, technical documentation, and retained evidence.
- [When can clinical equivalence be used under the EU MDR?](/artifacts/eu/medical-device-regulation/faq/equivalence.md): EU MDR FAQ on clinical equivalence, including technical, biological, and clinical characteristics, access to equivalent-device data, class III and implantable-device limits, clinical evaluation, PMCF, and retained evidence.
- [When do software or products make medical purpose claims under the EU MDR? | EU MDR FAQ](/artifacts/eu/medical-device-regulation/faq/medical-purpose-claims.md): EU MDR FAQ on medical purpose claims, intended purpose evidence, software qualification, Annex XVI contrasts, and records to keep.
- [When is a PSUR required under the EU MDR and what should it contain? | EU MDR FAQ](/artifacts/eu/medical-device-regulation/faq/psur.md): EU MDR FAQ on PSUR scope, content, update cadence, PMS and PMCF links, notified-body handling, EUDAMED submission, and evidence to retain.
- [When is an accessory regulated under the EU MDR? | EU MDR FAQ](/artifacts/eu/medical-device-regulation/faq/accessories.md): EU MDR FAQ on when an article is a medical device accessory, how intended purpose affects classification, and what evidence to keep.
- [When is software regulated as SaMD under the EU MDR? | EU MDR FAQ](/artifacts/eu/medical-device-regulation/faq/software-and-samd.md): Concise EU MDR FAQ on software qualification, intended medical purpose, Rule 11 classification, modules, clinical evidence, change assessment, UDI, and EUDAMED.
- [Which devices need an SSCP under the EU MDR and what should it include? | EU MDR FAQ](/artifacts/eu/medical-device-regulation/faq/sscp.md): EU MDR FAQ on when an SSCP is required, who prepares, validates, uploads, and updates it, and what evidence should support the summary.
- [Which EUDAMED modules matter under the EU MDR? | EU MDR FAQ](/artifacts/eu/medical-device-regulation/faq/eudamed-modules.md): EU MDR FAQ mapping EUDAMED modules to actor registration, UDI/device data, certificates, clinical investigations, vigilance/PMS, market surveillance, and practical records.

*Recommended next step*

*Placement: after implementation section*

## 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.

- [Open Research Copilot](/solutions/research-copilot.md): Answer EU MDR UDI, EUDAMED, and traceability questions with cited outputs.
- [Talk through implementation](/contact.md): Review identifier grouping, label evidence, registration data, and change triggers.


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