Why Labeling Matters Under The IVDR

Under Regulation (EU) 2017/746 (IVDR), labeling it is a core safety and performance control. Labels and instructions for use (IFU) communicate the device’s identity, intended purpose, safe use conditions, residual risks, and traceability data to users and patients. IVDR makes this a legal obligation for manufacturers (Article 10), and also places duties on importers and distributors to verify language and completeness before placing devices on the EU market (Articles 13 and 14). 

Scope: What Counts As “Labeling”?

IVDR treats labeling broadly to include:

• The label on the device and/or immediate and sales packaging

• Instructions for use (IFU) in paper or electronic form (where allowed)

• Accompanying information: package leaflets, outer box information, UDI carriers, and, if applicable, symbols and safety notices

Legal Framework And Where To Look

• General obligations: Article 10 (Manufacturers); Articles 13 and 14 (Importers, Distributors)

• CE marking rules: Article 20

• UDI system: Article 24 and Annex VI (UDI assignment, carriers, data)

• Claims: Article 7 (no misleading claims)

• Information supplied with the device: Annex I, Chapter III (Sections 20 : label & IFU content, format, readability)

• Language: Article 10 and Annex I, Chapter III require information in an official EU language determined by the Member State(s) of sale

• Electronic IFU (where permitted): Commission Implementing Regulation (EU) 2021/2226 (applies to devices, including certain IVDs, under defined conditions)

• Assessment of required elements and structure of Labels and IFU against GSPR Annex II (Technical Documentation)

Core IVDR Labeling Content (Annex I, Chapter III, Section 20)

While details differ by product type, your label and IFU must, at a minimum, address the following (summarized from e.g., 20.1, 20.2, 20.3 etc..):

On the label

• Name/trade name of the device and manufacturer’s name and address (and Authorized Representative, if applicable)

• UDI matrix (UDI-DI/UDI-PI as required; Article 24 & Annex VI) and CE marking (Article 20)

• Lot number or serial number; expiry date or use-by date or manufacturing date as relevant

• Intended purpose/functional category (at least enough to identify correct use) and in vitro diagnostic designation

• Storage/handling conditions (temperature, humidity, light) and any sterility status/processing

• Warnings or precautions essential to safety (including biohazard where relevant)

• Special conditions of use (e.g., single-use) and any measuring function information if relevant

• Country-specific language: in the official language(s) required by the Member State(s)

UDI And Traceability (Article 24 & Annex VI)

• Assign a Basic UDI-DI (for certificates/technical documentation) and a UDI-DI/UDI-PI for each commercial unit and packaging level.

• Place the UDI carrier (AIDC + HRI) on the label/packaging at the correct level(s).

• Register core data in EUDAMED (once fully functional) and maintain UDI records in your QMS.

• Ensure UDI is readable, scannable, and consistent across artwork, ERP, and packaging specifications.

Language, Readability, And Format

• The Member State(s) of sale determine the required language(s) (Annex I, Chapter III; Articles 10, 13 and 14).

• Information must be clear, legible, and indelible; layout should avoid critical information being obscured by seals or folds.

• Use standardized symbols to reduce translation load and improve comprehension (see ISO 15223-1).

• When using eIFU, comply with Regulation (EU) 2021/2226 conditions (e.g., risk profile, provision of paper on request, robust website and version control).

Things Manufacturers Commonly Miss On Labels

1. CE Marking – The CE marking symbol must be at least 5 mm in height on the label. If the small label size does not allow for a 5 mm symbol, it should not be included.

2. Label Symbols – All symbols appearing on the label must be identical to those used in the IFU (Instructions for Use) to maintain consistency and compliance.

3. Manufacturing and Expiry Dates – The expiry date must always be mentioned on the label. The manufacturing date should be included when space permits.

4. Please include Notified body number below the CE mark.

5. The Provided Labels are only in English please as per IVDR regulation the Labels must contain all the official languages of the countries which the device is being marketed.

Using International Standards To Strengthen Compliance

ISO 15223-1: Medical device symbols

ISO 15223-1 lists standard symbols (e.g., manufacturer, authorized representative, consult IFU, sterile, single-use, temperature limits, CE mark context, biological risks). Adopting these symbols helps you:

• Communicate safety-critical information without text or with minimal text

• Reduce label real estate pressure and translation burden

• Align with Notified Body expectations for state-of-the-art labeling practices

ISO 18113-1: IVD labeling (terms, definitions, general requirements)

ISO 18113-1 (and the related parts for reagents, calibrators, controls, instruments, and kits) provides structure and terminology for IVD labeling and IFU content, including:

• Consistent definitions of terms used on labels and IFUs

• Minimum content sets for reagents and instruments (e.g., measurand, traceability, metrological performance)

• Result interpretation, limitations, and quality control guidance
  Using ISO 18113-1 harmonizes your content with international practice and supports Annex I expectations on clarity and completeness.

Practical Impacts On IVD Manufacturers

1. QMS integration (Article 10): Labeling becomes a cross-functional, controlled process—linking Regulatory, Clinical/Performance Evaluation, R&D, Quality, Supply Chain, and Artwork.

2. Design inputs & risk management: Label content reflects intended purpose and residual risks from your risk files; changes to use conditions often trigger labeling updates and CAPA/Post-Market Surveillance links.

3. Performance claims alignment: Any claim on the label/IFU must be substantiated by your Performance Evaluation Plan/Report—and must not be misleading (Article 7).

4. Global artwork control: Expect more SKUs due to language combinations; plan for variable data management (UDI-PI, expiry, lot).

5. Supplier control: Printers/packagers become critical suppliers; validate processes (readability, permanence, barcodes).

6. Market surveillance readiness: Clear labeling speeds complaint handling, FSCA execution, and trend analysis.

Advantages Of Strong Labeling Compliance

• Regulatory clearance & smoother NB reviews: Clear, standard-aligned labeling reduces back-and-forth with Notified Bodies.

• Lower field risk: Users can select specimens, run tests, and read results correctly reducing invalids and reportable incidents.

• Operational efficiency: Standard symbols and well-structured IFUs cut translation costs and minimize rework.

• Commercial credibility: Professional, consistent labeling builds trust with laboratories, clinicians, and distributors.

• Traceability: Robust UDI and batch identification accelerate targeted recalls and vigilance actions.

Common Pitfalls To Avoid

• Over-claiming performance or intended use (Article 7)

• Missing or incorrect UDI carrier placement/levels (Article 24; Annex VI)

• Language gaps for specific markets or missing IFU translations

• Inconsistent symbols or mixing non-standard icons with ISO 15223-1

• IFU missing limitations, interferences, or QC guidance (contrary to Annex I, Chapter III)

• Poor barcode print quality or labels that degrade in cold/condensation conditions

Conclusion

Labels aren’t just stickers under the IVDR; they're how you prove your test is safe to use, easy to understand, and traceable. When your label and IFU clearly explain the intended use, include UDI, and follow ISO 15223-1 and ISO 18113-1, users can run your test correctly and regulators can see you’re in control. The result is practical: fewer questions from Notified Bodies, fewer field issues, and faster, smoother launches across EU markets.

How We Can Help

We design and implement end-to-end IVDR labeling systems requirements mapping, ISO-aligned templates, artwork controls, UDI data governance, and multilingual rollout so your files pass review and your products ship with confidence. If you’d like, we can tailor a label/IFU matrix to your portfolio and target Member States.