Before a notified body audit or an internal release review, this checklist covers the specific points where medical device labels most commonly fail — drawn from the requirements covered in the Medical Device Labeling Requirements guide. Work through each section against the device or product family under review.
This checklist is a working reference, not a substitute for the full regulatory text. Verify specific requirements against EU MDR (Regulation (EU) 2017/745), 21 CFR Part 801, and the current version of ISO 15223-1 before finalizing any label.
Device Label Content
☐ Device name, model, and trade or common name are correctly stated
☐ Manufacturer name, registered trademark, and registered address are current
☐ EU Authorized Representative name and address are present (non-EU manufacturers) and reflect the current AR arrangement
☐ Country of manufacture is stated where required for identification
☐ Lot number, serial number, software version, or catalogue number is accurate and matches the production record
☐ Manufacturing date and/or expiry date is unambiguous and correctly formatted
☐ Intended purpose is stated where not immediately obvious from the device itself
☐ Route of administration is stated where applicable
☐ CE marking and notified body identification number are present and correct (where notified body conformity assessment applies)
☐ Any special storage or handling conditions are stated
☐ Required warnings and precautions are present and current
UDI Verification
☐ UDI-DI (Device Identifier) is correct for this specific device model, labeler, and packaging configuration
☐ UDI-PI (Production Identifier) — lot, serial, manufacturing date, or expiry — is accurate and matches the production record
☐ UDI carrier appears on the device or sterile barrier system (where applicable)
☐ UDI carrier appears on the sales/unit packaging
☐ UDI carrier appears on all higher levels of packaging (intermediate and case)
☐ UDI-DI is consistent across all packaging levels — unit, intermediate, and case match
☐ AIDC (machine-readable) format is correct for the device class — DataMatrix for implantable/Class III, DataMatrix or linear barcode for other classes
☐ HRI (human-readable interpretation) matches the AIDC-encoded data exactly
☐ Barcode/DataMatrix has been graded to ISO/IEC quality standards (15415 for 2D, 15416 for linear)
☐ UDI-DI is registered in EUDAMED (mandatory for new devices from May 28, 2026; legacy devices by November 27, 2026)
IFU Compliance
☐ IFU content covers intended purpose, intended users, performance characteristics, and limitations
☐ Contraindications, warnings, and precautions are current and complete
☐ Residual risks and side effects are disclosed
☐ Installation, commissioning, and operating instructions are accurate for the current device configuration
☐ Cleaning, disinfection, and maintenance instructions are current
☐ IFU references the correct device model(s)
☐ Date of issue or latest revision is stated and current
☐ IFU is available in the official language(s) of every EU member state where the device is marketed
☐ If using eIFU: device and use case qualify under Commission Implementing Regulation (EU) 2021/2226 (professional users, not single-use for individual patients)
☐ If using eIFU: physical label carries the URL or access method, and a paper copy is available on request at no charge
☐ Every language version of the IFU has been verified against the source-language master, not just proofread independently
Symbol Accuracy (ISO 15223-1)
☐ All symbols on the label reference ISO 15223-1:2021, not the superseded 2016 version
☐ Symbol usage matches MDR Annex I Section 23 — text description is available where symbols may not be universally recognized
☐ Manufacturer, Authorized Representative, date of manufacture, and use-by symbols are current and correctly rendered
☐ Sterile, single-use, and lot/catalogue number symbols are correctly placed and sized
☐ Symbol accuracy has been verified through graphic (pixel-level) comparison against the approved master artwork, not visual inspection alone
Language and Market Verification
☐ Every language version required for the target market(s) is present
☐ Each language version has been compared against the approved master — not just proofread independently
☐ Language versions have been cross-checked against each other for consistency, not just against the master individually
☐ Jurisdiction-specific requirements (beyond translation) have been verified per market
Documentation and Audit Trail
☐ The comparison or review process used to verify this label produces a timestamped, tamper-proof audit trail
☐ The audit trail identifies who performed the review, what was compared, against which master version, and what deviations were found
☐ Any software used in the verification process has current validation documentation (IQ/OQ/PQ) appropriate to a GxP-regulated process
☐ Sign-off is tied to a specific, identifiable document version — not a file name that could apply to more than one revision
☐ Records are retrievable without reconstruction in the event of a notified body or FDA inspection
If any item above is unchecked or uncertain, that is the specific point to address before the label is finalized for release. The most common source of medical device labeling non-conformities is inconsistency between packaging levels, not an error on any single label — cross-checking every level against every other level, and against the approved master, is the step that catches what individual review misses.
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