Since the Medical Device Regulation (MDR) came into effect, medical device companies have had to rethink how they approach labeling for the EU market. What used to be a checklist item has become a critical compliance function. Today’s labels carry more responsibility, from traceability to clear usage instructions, and the pressure to get it right has never been higher.
Introduction to Medical Device Labelling
MDR labeling requirements have fundamentally changed how medical device manufacturers approach compliance in the EU market. With stricter enforcement, enhanced traceability demands, and more information requirements, getting labeling right has become essential for maintaining market access and ensuring patient safety. Medical device labeling under the Medical Device Regulation (MDR 2017/745) covers everything from the tiny text on your device to the thick instruction booklets users actually read. It represents all the information you provide to identify your device and explain how to use it safely.
The industry's transition from Medical Device Directive (MDD) to MDR has made labeling significantly more complex. For many manufacturers, this shift came at the same time as another market disruption: Brexit left the UK operating under its own UK Medical Device Regulations, which largely carried forward the requirements of the older MDD framework, while the EU moved ahead under MDR. This divergence forced companies selling into both markets - including England, Scotland, and Wales - to maintain two parallel labeling strategies. For regulatory and quality teams already under pressure, the dual system quickly became a major hurdle, adding time, cost and complexity at exactly the moment when MDR was already raising the bar across the EU.
The new regulation demands safety and performance information that genuinely helps healthcare professionals and patients use devices correctly. That means more detailed technical descriptions, better traceability systems, and clearer warnings about residual risks. The EU market expects manufacturers to think harder about what information their intended users actually need versus what regulators require. At its core, patient safety drives every labeling requirement because clear device labels help ensure safe and effective use, which explains why MDR enforcement focuses heavily on labeling compliance with meaningful consequences for manufacturers who fall short.
Understanding the Medical Device Regulation (MDR 2017/745)
The regulation covers devices intended for human use ranging from simple bandages to complex implants that interact with the human body. If your device touches patients, these labeling requirements apply to you. This includes accessories, software medical devices, and custom made devices that each have specific considerations. Class III devices, implantable devices, and everything down to basic Class I products all fall under these rules.
The shift from MDD to MDR brought major changes to what you need on your labels. Under the old Medical Device Directive, basic identification and some safety warnings were enough. Now MDR demands comprehensive safety and performance information, detailed technical descriptions, stronger traceability through UDI systems, and clearer warnings about residual risks. You need better connections between your labeling and quality management system, plus documentation showing how your labels support clinical investigation outcomes.
Implementation timelines started May 26, 2021 when MDR became fully enforceable. Class III devices and implantable devices faced the toughest requirements first, while lower-risk devices had transition periods. Enforcement has ramped up significantly since then, with notified bodies now scrutinizing labeling decisions much more carefully than before, particularly how your labels address residual risks identified in your risk management process.
Chapter III of Annex I lays out the foundation that's much more demanding than what came before. This section, titled "Requirements regarding the information supplied with the device," establishes three critical areas where Section 23.1 covers general requirements for manufacturer-supplied information, Section 23.2 details specific label content requirements, and Section 23.3 handles sterile packaging requirements. Annex I, Chapter III also permits the use of supplemental machine-readable formats - including barcodes or RFID tags - when appropriate. These formats support traceability but are not a substitute for clear, human-readable information. That includes elements like serial numbers, lot identifiers, or warnings tied to specific risks, all of which must be presented in ways users can easily interpret. Reviewing these guidelines early on can make it easier to design labels that both meet regulatory expectations and hold up under scrutiny.
CE Marking Requirements Under MDR
CE marking is your device's passport to the EU market - it's the manufacturer's declaration that your device meets all applicable EU requirements for safety, health, and environmental protection. When healthcare professionals and patients see the CE mark on your medical device, they know it's been assessed for compliance with MDR standards and can be legally sold throughout the European Economic Area. Without proper CE marking, your device can't enter the EU market regardless of how good your product actually is.
Getting CE marking authorization requires following the conformity assessment procedures outlined in MDR Annex IX through XI, depending on your device class. For Class I devices, you can self-declare conformity and affix the CE mark after completing technical documentation and risk analysis. Higher-risk devices need notified body involvement where they review your technical documentation, quality management system, and clinical evidence before authorizing you to use the CE mark. MDR tightened these requirements compared to the old Medical Device Directives with much more demanding post-market surveillance obligations, increased clinical evidence requirements especially for Class III devices and implantable devices, and more rigorous notified body oversight with deeper technical reviews.
The CE mark itself must appear visibly, legibly, and indelibly on your device or its packaging according to specific formatting rules. If size limits apply, MDR allows CE marking on the IFU instead, but only when space constraints prevent labeling. It needs to be at least 5mm high (or proportionally sized if your device is smaller), and if a notified body was involved in your conformity assessment, their identification number must appear immediately after the CE mark. You can't modify the proportions or add decorative elements to the mark, and it must be placed where it's easily visible to users without having to disassemble anything. Getting the CE mark placement right is just one part of designing labels that include all the essential information your users need to identify and safely use your device.
Essential Information Required on Medical Device Labels
Every medical device label needs specific mandatory elements under Annex I, Chapter III, Section 23.2 of the MDR. Start with basic identification where your serial number, lot number, and batch number provide traceability throughout the supply chain. You also need your company name and address clearly visible since a simple postcode or web address isn't enough. Intended purpose and intended use information should help users understand what your device actually does. Stick to clear, factual descriptions of how it should be used and by whom - skip the marketing copy.
Labels must include an indication that the device is a medical device, though there's no universal symbol for this. Between CE marking, notified body numbers, and authorized representative information, you're usually covered on this requirement. For devices containing medicinal substances, tissues or cells of human origin, or tissues or cells of animal origin, specific labeling becomes mandatory. Once you've covered all the mandatory elements, you need to consider three critical aspects of how that information appears on your labels:
Information hierarchy and placement - The most critical safety information needs to appear prominently where users will actually see it. Quantitative information about device specifications, handling conditions, and special storage requirements needs clear visibility throughout the label design. When safety information is easy to spot, it’s easier for users to do the right thing, even under pressure.
Language requirements - Article 10 (11) mandates that label information must be provided in official languages accepted in national markets where you're selling, though some countries require information in their official languages which creates challenges when you're trying to fit everything on a small label. You need strategies for managing multilingual requirements without compromising readability, though for devices supplied only to healthcare professional users, English may be acceptable in some markets.
Safety warnings and risk information - Warning information about residual risks, contraindications, and specific monitoring requirements must be clear and understandable so users know what could go wrong and how to prevent problems before they occur. This safety information often drives the most critical labeling decisions you'll make.
These essentials set you up for the next challenge: using symbols to manage space constraints without losing compliance.
Symbols and Standards: EN ISO 15223-1:2021
The updated EN ISO 15223-1:2021 standard gives you new internationally recognized symbols that can replace some text-based information on your labels, which helps when you're struggling with space constraints or multilingual requirements. The harmonized standard includes 25 new symbols beyond what was available in the 2016 version. These cover everything from updated sterile barrier system symbols to new implant identification requirements. Key new symbols include enhanced sterile packaging indicators, biological risk warnings, and specific symbols for implantable device identification cards that address real labeling challenges manufacturers face under MDR.
Implementation varies by manufacturer and device type, but the European Commission harmonized this standard in 2022, making it available for MDR compliance. You should evaluate your current labels against the updated standard since using standardized symbols correctly can make your labels clearer and more space-efficient. The key is consistency - symbols must match the standard exactly because users rely on symbol recognition across different devices and manufacturers, while variations can cause confusion among healthcare professional users. For devices intended for lay users, symbols must always be explained in the instructions for use since manufacturers can't assume laypeople will understand symbols without explanation.
You can replace certain text elements with symbols when they're internationally recognised according to MDR Annex I Chapter III Section 23.1(h), but this doesn't work for all information types. Essential safety warnings, device-specific instructions, and complex technical information typically still need text explanations alongside symbols. The standard helps you determine which information works well as symbols versus what needs to stay as text to maintain user safety and regulatory compliance. When symbols aren't enough to convey all the information users need, electronic instructions can provide another solution for comprehensive device guidance.
Electronic Instructions for Use (eIFU)
Electronic instructions let you provide detailed information without massive paper booklets, but there are specific rules around eIFU that you need to follow. You can use electronic instructions for professional users under certain conditions outlined in Commission Regulation (EU) 2021/2226, as amended by Commission Implementing Regulation (EU) 2025/1234 which expanded what's allowed if adopted. The regulation permits eIFU when your device is intended exclusively for professional users and when you meet specific accessibility requirements.
You can't use eIFU for devices intended for home use by patients. Single-use sterile devices, implantable devices, and Class III devices often require paper instructions regardless of user type. Certain sterile condition products where electronic access might be impractical during use also need paper instructions.
Don't assume eIFU works for every situation - check the specific requirements for your device category first. When eIFU is allowed, your instructions on how to access the electronic information need to be crystal clear. The information needs to stay available throughout your device's intended lifespan, and you must provide a website address on the label where users can find the eIFU. Software medical devices get more flexibility since they often integrate instructions directly into user interfaces, but you still need to ensure all essential safety and performance information reaches users in a format they can access and understand when needed.
Unique Device Identification (UDI) Requirements
UDI gives every device a unique identifier that tracks it across the EU market, kind of like a barcode system but much more comprehensive. The system has two main parts: the UDI-DI (device identifier) that stays the same for your specific device model, and the UDI-PI (production identifier) that includes variable data details like serial number, batch number, manufacturing date, or expiry date. Think of the UDI-DI as your device's permanent ID card, while the UDI-PI tells you exactly which unit you're looking at.
The compliance deadlines are non-negotiable and depend on your device class. Class III devices and implantable devices had to comply by May 26, 2021. Class IIa and IIb devices needed UDI carriers by May 26, 2023. Class I devices face the upcoming deadline of May 26, 2025. If you have reusable devices where the UDI carrier goes directly on the device itself, you get an extra two years - so Class I reusable devices have until May 26, 2027. This applies only to direct marking on reusable Class I devices; labeling and packaging still follow earlier deadlines.
Here's how to make it work: You need to get your UDI codes from an approved issuing entity like GS1, then register both your UDI-DI and Basic UDI-DI codes in EUDAMED once it becomes fully functional. The UDI carrier must appear on your device labels and packaging where it'll stay legible throughout your device's use without interfering with other essential information. Plan the placement carefully because users need to actually find and read the identification when they need it. The whole system connects your device identification with regulatory oversight, affecting how you document devices and maintain compliance records for authorities, which ties directly into the broader traceability requirements that extend throughout your entire labeling strategy.
Ensuring Traceability Through Labelling
Supply chain traceability requirements mean your device labels need identification information that supports tracking devices from manufacturing through distribution to actual use. Basic device identification isn't enough. Labels should provide information that allows problems to be traced when they occur, backed by comprehensive records linking each device to production data and your quality management system documentation. You’ll also need evidence that your labeling compliance and traceability processes work in practice. Post-market surveillance makes this even more critical because your labels must support identification of devices involved in adverse events or other safety concerns that pop up after market introduction. When problems occur, you need to trace affected devices quickly and accurately to protect patients and maintain regulatory standing. These traceability challenges get even more complex because different device categories have their own specialized labeling requirements beyond just the basics.
Special Labelling Requirements for Specific Device Categories
Implantable devices face the most demanding labeling requirements because they stay in the human body long-term, requiring specific information about biocompatibility, expected device life, and any special monitoring requirements for patients and healthcare professionals. These devices need comprehensive material information and long-term safety data that other categories don't require. Single-use devices need equally clear labeling about reprocessing risks and why the device should never be reused, with information that makes it obvious that attempting to reprocess could compromise device safety and effectiveness.
Professional use versus home use devices need completely different approaches because healthcare professionals can handle more technical language and complex instructions, while patient-facing devices need simpler, clearer guidance that matches the user's knowledge level. Custom made devices and investigational devices get some regulatory flexibility since they're designed for specific situations rather than broad market use, but they still need essential safety warnings even though some standard requirements may not apply. These specialized products often go to users with specific training or clinical oversight.
Device accessories often get overlooked, but they need their own identification and safety information since accessories that affect device performance or safety need labeling that explains their proper use and limitations. Don't assume users will automatically understand how accessories work with your main device. Getting these specialized requirements right becomes especially important when you're facing compliance challenges that could derail your entire labeling strategy.
Common Compliance Challenges and Solutions
Frequent labeling non-conformities identified by notified bodies include incomplete safety information, inadequate traceability elements, and poor consideration of intended user needs. Labeling is easier to get right, and harder to miss, when it’s built into the development process from the start. Handling multilingual content adds another layer of complexity. Staying consistent across regions calls for a structured and repeatable method. Any updates to labels should follow a clear change control process, particularly when changes affect multiple markets at once.
Before labels can meet MDR expectations, it’s important to take a close look at what’s already in use. That review should include checking for any gaps against current regulations, as well as keeping track of relevant transition timelines or exemptions by device category. Once that’s clear, the next step is to follow a structured process that makes compliance more consistent and easier to manage.
- Start with the core regulation: A good starting point is Annex I, Chapter III, Section 23.2, which outlines the mandatory labeling elements. Look specifically at what applies to your device’s classification, how it’s used, and who the end user is.
- Gather the required identifiers: Collect the details needed to identify your device and manufacturer, including the product name, company address, intended use, serial or lot numbers, and your assigned UDI codes.
- Evaluate opportunities to simplify with symbols: Check which text-based elements can be replaced with ISO 15223-1:2021 symbols. This can help reduce translation needs and improve clarity in space-constrained layouts.
- Organize key information thoughtfully: Make sure essential safety details are placed where users will see them first, and that traceability elements remain easy to find throughout the device’s use.
- Address language requirements early: Each country may have different rules. Confirm what’s needed for each market and adjust your label layout to handle translations clearly and consistently.
- Build in quality checkpoints: Set up checks for things like translation accuracy, print quality, and how labels are applied - all of which affect final usability and compliance.
- Document the rationale behind your decisions and keep a master record: Show how each part of your label ties back to a regulation, a clinical data point, or a specific risk you’re addressing. It also helps to save a master label for each SKU using a standard naming convention. This gives your team a clearer reference point, the version you know meets all MDR rules. New labels can then be compared against the master, helping you spot differences quickly and avoid accidental gaps in compliance.
- Prepare for ongoing updates: Develop a structured process for reviewing, approving, and implementing changes. Be sure to factor in notification timelines and market-specific approval pathways.
When managing multiple product lines, it’s often easier to work from a base label design and adapt it as needed. Each version should still reflect the specific risks, clinical findings, and usage conditions tied to that device.
Consequences of Non-Compliance
When regulatory authorities find labeling problems, they can shut down your device sales across member states until you fix the issues. Losing market access can drain millions of dollars from your business. Beyond direct fines or withdrawal orders, manufacturers face the costs of relabeling, corrective actions, and delayed sales, while revenue lost during downtime and the struggle to regain market share compound the damage. Industry data from GMP SOP’s deviation investigation guidelines shows even minor errors caught before distribution can cost $150,000-$2.5 million, while recalls with no patient harm average $12.5-$65 million. At the high end, major errors tied to patient safety risks can escalate to $110-$700 million.
For companies with broad portfolios, the financial impact of a single labeling deficiency can multiply quickly, turning what looks like a technical error into a multi-million-dollar setback. These interruptions also affect your ability to serve patients and protect your market position, and even after compliance is restored, the costs of market re-entry add to the financial strain.
Legal problems can get much worse than regulatory penalties because inadequate labeling that contributes to patient harm or device misuse opens you up to product liability claims. Courts increasingly recognize labeling deficiencies as contributing factors in medical device litigation, so poor labeling decisions can expose your company to lawsuits that go way beyond the original regulatory violation. Once you're on authorities' radar for labeling problems, they'll scrutinize everything else you do much more carefully through enhanced oversight, stricter penalties for repeat offenses, and increased coordination between member states that means your reputation follows you across the EU.
Implementing a Robust Labelling Control Process
Your labeling decisions need to connect directly to your broader device development and manufacturing controls, which means integrating labeling into your quality management system rather than treating it as a separate compliance task. This integration helps ensure your labeling supports your risk management and clinical evidence while creating consistency between what your devices actually do and how you describe them to users. Post-market surveillance activities should also feed back into your labeling decisions as you learn more about real-world device performance.
Strong validation gives you confidence that what you’ve documented is actually working in practice, not just on paper. This goes beyond just checking spelling and grammar to include validating your translation processes along with printing controls that affect final label quality. Test your labels with actual users when possible to make sure the information works in real-world situations, not just on paper.
Change management procedures must account for regulatory notification requirements and coordination with ongoing clinical investigation activities because labeling changes can't happen in isolation. Set up a review process that makes it easy to update labels when needed, while also keeping tight control over what gets changed. It’s also worth checking how each country handles label approvals, since timelines and steps can vary across markets. Documentation requirements include comprehensive records showing compliance with applicable labeling standards, user feedback on label effectiveness, and ongoing monitoring of labeling performance in real-world use conditions that help you improve your approach over time, especially when preparing for notified body reviews that scrutinize every aspect of your labeling decisions.
The Role of Notified Bodies in Label Review
Notified bodies have gotten much more demanding about labeling under MDR. They want comprehensive evidence that your labels actually support device safety and effectiveness claims. Gone are the days when checking boxes for technical requirements was enough.
What are they looking for during reviews? Safety warnings get heavy scrutiny - they want to see that you've addressed residual risks properly and that warnings make sense for your intended users. They'll check whether your labeling matches your technical documentation and clinical evidence. If something doesn't line up, expect questions. User appropriateness is another big focus area. Your labels need to match the knowledge level of whoever's using your device. Professional-use devices can handle more technical language, but patient-facing labels better be crystal clear. Notified bodies pay close attention to how well you've thought through who's actually reading these labels.
Preparing for successful assessments means organizing your documentation so reviewers can easily connect your labeling decisions to your clinical evidence and risk analysis. You need to explain not just what information you included, but why you chose to present it the way you did. They want to see your reasoning process, not just your final output.
Global Harmonization Considerations
Managing medical device labeling across multiple markets creates real headaches when regulations don't align. The EU's MDR requirements often conflict with FDA standards, creating situations where what works for European compliance won't work in the US market. A unified approach helps simplify complexity across regions and support your team in delivering safe, consistent labeling worldwide.
The biggest differences between MDR and FDA requirements show up in three key areas:
- Symbol standards vary significantly - what's acceptable under ISO 15223-1 for European markets might need different approaches for FDA submissions.
- Language requirements create another challenge since MDR demands official language compliance in member states while FDA focuses primarily on English with different multilingual considerations.
- Electronic instructions represent the third major split, where MDR allows eIFU under specific conditions but FDA maintains stricter requirements for paper documentation in many device categories.
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Building efficient global compliance starts with master labeling templates that accommodate the most restrictive requirements from both systems. Design labels that satisfy MDR's comprehensive information requirements while meeting FDA's specific formatting expectations. Coordinate approval processes that account for different timelines and submission requirements across regions. The documentation challenge means managing validation records that satisfy both MDR's traceability demands and FDA's quality system requirements without creating duplicate work that doesn't add value.
Successful manufacturers develop labeling strategies that treat global compliance as an integrated challenge rather than separate regional problems. Think through how your label design decisions affect multiple markets from the start instead of retrofitting compliance after the fact.
Future Trends in Medical Device Labelling
Digital labeling capabilities are advancing rapidly beyond today's basic electronic instructions. While manufacturers already use interactive PDFs and connected device updates, more sophisticated content delivery and real-time safety updates are coming. When they arrive, you'll need new ways to validate dynamic content that changes after initial approval.
Sustainability requirements are tightening from current voluntary initiatives to mandatory compliance standards. Many manufacturers have already adopted recyclable materials and reduced packaging, but new regulations will demand environmental impact assessments and waste reduction targets. This shift affects more than just materials - it changes how you design labels from the ground up. Companies that treat sustainability as a compliance checkbox rather than a design priority will face higher costs and market access challenges.
Regulatory changes will accelerate to keep pace with technological advances. Electronic instructions will expand beyond professional-use devices as regulators figure out how to validate dynamic content for patients. The biggest shift will be tighter integration between labeling requirements and post-market surveillance systems, where label updates become part of ongoing safety monitoring rather than separate regulatory events. As these trends accelerate, strong verification processes become critical to ensure your labels meet changing requirements while maintaining compliance across global markets.
GlobalVision's Verify platform helps medical device manufacturers ensure their labels meet all regulatory requirements while maintaining efficiency across global markets. See how automated verification catches errors before they reach the market.
