Most medical device companies are aware that EU MDR 2017/745 changed labeling requirements. Fewer have worked through exactly what those changes mean at the level of a specific label revision — and the gap between knowing MDR exists and implementing it fully is where notified body findings consistently originate.
This isn't a comprehensive MDR labeling checklist. It's a focus on the specific requirements that device teams most regularly misinterpret or overlook in practice.
UDI: The Consistency Requirement That Gets Missed
The UDI requirement under MDR is widely understood in principle. What gets missed in practice is the consistency obligation across all packaging levels. Under Articles 27, 28, and 29 and Annex VI of Regulation (EU) 2017/745, UDI must appear on the device itself, on its packaging, and on all higher-level packaging. Every level must carry its own UDI carrier — both in machine-readable AIDC format and in human-readable HRI form. A common audit finding is mismatched UDI information between the unit-of-use label and higher packaging levels — MDR requires complete consistency, since any mismatch creates a traceability failure.
The EUDAMED UDI/device module became mandatory as of May 28, 2026. For new devices, registration must be completed before market placement. For legacy devices already on the market at that date, registration is required by November 27, 2026, per Regulation (EU) 2024/1860 amending the MDR transition provisions.
Language Requirements Are Jurisdiction-Specific
MDR requires that labels be in the official language or languages of the EU member state where the device is marketed. A single multilingual master label that covers all target markets may satisfy all the relevant language requirements — or it may not, depending on how those languages are presented and which jurisdictions are involved.
Language localization enforcement across EU member states has been identified as an increasing notified body audit focus. Devices being sold in multiple EU markets with a single label version need to have that label formally verified for each jurisdiction's language requirements, not assumed to be compliant. The language obligations are set out in MDR Annex I, Chapter III.
Symbol Updates Under ISO 15223-1:2021
EU MDR recognizes and accepts ISO 15223-1:2021 symbols. The regulation specifies that internationally recognized symbols can replace text descriptions — with the important caveat that in markets where the symbols are not recognized, written descriptions must be provided alongside. This is addressed in MDR Annex I, Chapter III, Section 23.1(h).
Manufacturers who updated their device labels for MDR compliance when the regulation first came into force may now be running artwork that references an earlier symbol standard. Symbols that were compliant in 2021 should be verified against the current version of ISO 15223-1 before new label releases.
The Authorized Representative Requirement for Non-EU Manufacturers
Non-EU manufacturers must include the EU Authorized Representative's contact details on commercial labels, per MDR Article 11. This is a distinct and additional requirement from the manufacturer's own contact information. Importers also bear responsibility: they must verify that non-EU manufacturers have included authorized representative details and that the device meets all MDR requirements before placing it on the market.
When label updates are made — for any reason — the authorized representative information needs to be verified as current. Representative relationships change; contact details change. A label that accurately reflected the AR arrangement at initial approval may not accurately reflect it at the next revision.
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