Medical Device Labelling Requirements in Europe: MDR & IVDR Compliance Guide

    Created at: 10 August 2021 - Last updated: 27 August 2026

    Reading Time: 8 min
    Medical Device Labelling Requirements in Europe: MDR & IVDR Compliance Guide
    Bringing a medical device or in vitro diagnostic (IVD) to the European market involves more than obtaining regulatory approval. Manufacturers must also ensure that product labels, packaging and instructions for use comply with the requirements set out under the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR).

    Labelling plays a critical role in patient safety, traceability and regulatory compliance. Incorrect or incomplete labelling can delay market access, trigger compliance findings during audits, or lead to issues during post-market surveillance activities.

    For manufacturers expanding into Europe, understanding these requirements early can help avoid costly delays and support a smoother commercial launch.

    Bonus read: UK Medical Device Regulation Changes: Key Considerations


    What Changed Under MDR and IVDR?

    The European regulatory framework for medical devices has undergone significant changes in recent years.

    The Medical Device Regulation (MDR) (EU 2017/745) replaced the former Medical Device Directive (MDD), while the In Vitro Diagnostic Regulation (IVDR) (EU 2017/746) replaced the In Vitro Diagnostic Directive (IVDD).

    Compared with the previous directives, MDR and IVDR place greater emphasis on:

    • Product traceability
    • Transparency
    • Post-market surveillance
    • Clinical and performance evidence
    • Unique Device Identification (UDI)
    • Clear and consistent labelling

    As a result, manufacturers must review not only their technical documentation but also the information displayed on labels, packaging and instructions for use.

     

    Why Medical Device Labelling Matters


    Medical device labels provide essential information that enables healthcare professionals, distributors, regulators and patients to identify and use products safely.

    Proper labelling helps ensure:

    • Device traceability throughout the supply chain
    • Correct product identification
    • Safe and effective use
    • Compliance with EU regulations
    • Efficient recalls and field safety corrective actions when required

    For companies entering multiple European markets, labelling also serves as an important tool for communicating product information across different languages and healthcare systems.

     

    Key Medical Device Labelling Requirements Under MDR and IVDR


    While requirements vary depending on device type, risk classification and intended use, several core elements apply to most products.

    Device Identification

    Labels must clearly identify the device and provide sufficient information for users to distinguish it from similar products.

    This typically includes:

    • Device name
    • Device model or reference number
    • Product description
    • Intended purpose where applicable

    The goal is to ensure healthcare professionals and users can accurately identify the product at every stage of the supply chain.

    Manufacturer Information

    Manufacturers must provide clear identification details on product labelling.

    Required information generally includes:

    • Manufacturer name
    • Registered address
    • Contact details where applicable

    For manufacturers based outside the European Union, additional labelling requirements may apply.

    EU Authorised Representative Details

    Non-European manufacturers placing products on the EU market must appoint an Authorised Representative (AR).

    The Authorised Representative's details must appear on the label or packaging as required under MDR and IVDR.

    Failure to properly identify the Authorised Representative remains one of the more common compliance issues encountered during regulatory reviews.

    Importer Information

    Medical devices entering the European Union through an importer must also include importer information where required.

    Importers assume specific regulatory responsibilities under MDR and IVDR and must be clearly identified within the supply chain.

     

    Unique Device Identification (UDI)


    One of the most significant changes introduced by MDR and IVDR is the implementation of the Unique Device Identification (UDI) system.

    UDI improves traceability by assigning devices a unique identifier that can be tracked throughout their lifecycle.

    The UDI system consists of:

    UDI-DI

    The Device Identifier identifies the product model and manufacturer.

    UDI-PI

    The Production Identifier contains variable production information such as:

    • Batch number
    • Serial number
    • Manufacturing date
    • Expiry date

    UDI requirements support:

    • Improved traceability
    • Faster recalls
    • Better post-market surveillance
    • Increased patient safety

    EuroDev Insight

    Many North American manufacturers discover that implementing UDI across European product portfolios requires coordination between regulatory, quality, manufacturing and commercial teams. Companies that begin planning early often experience smoother market entry and fewer labelling update projects after launch.

    Language Requirements Across Europe

    One of the most frequently underestimated challenges for manufacturers entering Europe is localisation.

    Unlike the United States, Europe is not a single market from a language perspective.

    Individual member states determine which languages are required for:

    • Product labels
    • Packaging
    • Instructions for use
    • Safety information

    Depending on the target markets, manufacturers may need multiple language versions of product information.

    Failing to meet local language requirements can delay product registrations, distributor onboarding and commercial launches.

    EuroDev Insight

    For companies targeting multiple European countries simultaneously, translation planning should begin well before market launch. Coordinating localisation efforts late in the process is a common cause of launch delays.

    Instructions for Use (IFU)

    Instructions for Use (IFU) remain a critical component of device compliance under MDR and IVDR.

    IFUs may need to contain:

    • Intended use
    • Contraindications
    • Warnings
    • Precautions
    • Operating instructions
    • Storage conditions
    • Disposal requirements

    For certain products, electronic Instructions for Use (eIFU) may be permitted under specific regulatory conditions.

    Manufacturers should carefully assess whether traditional paper IFUs, electronic IFUs or a combined approach is appropriate for their product category.

    Medical Device Symbols Used Under MDR and IVDR

    Symbols continue to play an important role in European medical device labelling.

    They help communicate important information in a consistent manner and reduce dependence on multiple language translations.

    Examples include symbols indicating:

    • Self-testing devices
    • Near-patient testing devices
    • Not-for-self-testing devices
    • Manufacturer information
    • Authorised Representative
    • Use-by date
    • Batch code
    • Catalogue number
    • Sterility information

    While symbols improve usability, manufacturers must ensure they are applied correctly and remain consistent with applicable standards and regulatory requirements. The original version of this blog focused primarily on several IVDR testing-related symbols, but manufacturers today must evaluate a much broader range of MDR and IVDR labelling obligations.

    Common MDR & IVDR Labelling Mistakes


    As regulatory expectations have increased, several recurring compliance issues continue to appear across the industry.

    Missing or Incorrect UDI Information

    Incomplete UDI implementation can affect traceability and regulatory compliance.

    Inadequate Translations

    Poorly translated labels and IFUs can create compliance and usability concerns.

    Missing Importer or Authorised Representative Information

    This remains a common issue for non-European manufacturers.

    Outdated Packaging

    Some manufacturers continue using packaging elements that reference previous regulatory frameworks.

    Inconsistent Product Information

    Differences between labels, technical documentation and Instructions for Use can create regulatory risks.


    Compliance Is More Than a Regulatory Exercise

    Labelling requirements are often viewed purely as a regulatory obligation. In reality, they also affect broader business activities, including:

    • Distributor onboarding
    • Market access
    • Tender participation
    • Healthcare professional adoption
    • Post-market support

    For companies expanding into Europe, labelling compliance should be considered part of the overall commercialisation strategy rather than a final regulatory checklist item.

    Key Takeaways

    • MDR and IVDR have significantly expanded labelling requirements for medical device manufacturers.
    • UDI implementation is now a central component of European device traceability.
    • Manufacturer, importer and Authorised Representative information must be carefully managed.
    • Language and localisation requirements remain a major challenge for international manufacturers.
    • Product labels, packaging and Instructions for Use should be reviewed as part of a comprehensive regulatory and commercial strategy.
    • Early planning can help avoid delays, reduce compliance risks and support faster European market entry.

     

    How Can EuroDev Help with Medical Device Labelling Standards?

    Through the offering of a variety of business expansion services, EuroDev has played a pivotal role in the European expansion of over 500 North American companies since 1996.

    Our expertise in the European medical device market can help you, too, to stay compliant with new EU medical device labelling standards. Your partnership with EuroDev can accelerate submissions and approvals for manufacturers who want to expand into these markets. Check out our Sales Outsourcing services to learn more about how we can assist you.

    Contact us today to schedule a call with our experts.

    Written by Med Tech & Life Sciences team at EuroDev.

    Sources

    1. European Commission. Medical Devices Regulation (EU) 2017/745
      [eur-lex.europa.eu]
    2. European Commission. In Vitro Diagnostic Regulation (EU) 2017/746
      [eur-lex.europa.eu]
    3. European Commission Medical Devices Sector
      [health.ec.europa.eu]
    4. European Commission EUDAMED Information
      [health.ec.europa.eu]
    5. MDCG Guidance Documents
      [health.ec.europa.eu]
    6. MedTech Europe
      [medtecheurope.org]

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