Updated: 30th June 2026
Reviewed by: David Small BSc (Hons), MSc, MTOPRA (Founder and CEO)
What Is Medical Device and IVD Labelling?
Medical device and in vitro diagnostic (IVD) labelling is far more than simply identifying a product. Under the EU Medical Device Regulation (EU MDR 2017/745) and the In Vitro Diagnostic Medical Devices Regulation (IVDR 2017/746), labelling is a critical component of regulatory compliance, providing users with the information they need to identify, use and handle devices safely throughout their lifecycle.
Labelling encompasses all information supplied with a device, including the product label, packaging, Instructions for Use (IFU), electronic instructions where permitted and the symbols used to communicate important safety and regulatory information. Together, these elements ensure that healthcare professionals, laboratory personnel, patients and distributors have access to clear, accurate and consistent information about the device.
Compliant labelling supports several essential regulatory objectives. It enables users to identify the manufacturer, understand the intended purpose of the device, recognise important warnings and precautions, maintain product traceability through Unique Device Identification (UDI) and use the device safely in accordance with the manufacturer’s instructions. Effective labelling also plays a vital role in Post-Market Surveillance, vigilance activities and product recalls by allowing devices to be rapidly identified and traced throughout the supply chain.
Both the MDR and IVDR contain detailed requirements governing the information that must appear on device labels and accompanying documentation. These requirements are primarily set out in Annex I, Chapter III of each Regulation and are supported by harmonised standards such as ISO 15223-1 for medical device symbols and international standards covering Unique Device Identification, usability and risk management.
This guide provides a comprehensive overview of medical device and IVD labelling under the MDR and IVDR, explaining the mandatory information that must be provided, the role of Instructions for Use, regulatory symbols, language requirements, UDI, common compliance pitfalls and best practices for maintaining compliant labels throughout the product lifecycle.
Need an Introduction to the EU MDR?
This article focuses on medical device labelling under the EU MDR. If you're looking for a complete overview of the Medical Device Regulation, including classification, GSPRs, technical documentation, UDI, CE marking and post-market obligations, read our Complete Guide to the EU MDR.
Need an Introduction to the EU IVDR?
This article covers IVD labelling requirements under the EU IVDR. If you're looking for a complete overview of the In Vitro Diagnostic Medical Devices Regulation, including classification, Performance Evaluation, General Safety and Performance Requirements, Technical Documentation, UDI, Notified Bodies and post-market obligations, read our Complete Guide to the EU IVDR.
Which Regulations Govern Medical Device and IVD Labelling?
Medical device and IVD labelling within the European Union is governed by the EU Medical Device Regulation (EU MDR 2017/745) and the In Vitro Diagnostic Medical Devices Regulation (IVDR 2017/746). Both Regulations establish comprehensive requirements to ensure that devices are accompanied by clear, accurate and consistent information that enables their safe use, supports traceability and facilitates regulatory oversight throughout the product lifecycle.
The primary labelling requirements are contained within Annex I, Chapter III of both Regulations, which forms part of the General Safety and Performance Requirements (GSPRs). These provisions specify the information that manufacturers must provide on device labels, packaging and Instructions for Use (IFUs), ensuring that users have sufficient information to identify the device, understand its intended purpose and use it safely.
Although the MDR and IVDR share many common labelling principles, there are important differences reflecting the nature of the products they regulate. Medical devices often require information relating to sterility, implantation, reusable components and software functionality, whereas IVDs frequently require additional information concerning specimen types, reagent preparation, analytical performance, storage conditions and intended testing environments.
Compliance with the MDR and IVDR also extends beyond the Regulations themselves. Manufacturers are expected to consider relevant harmonised and internationally recognised standards that support compliant labelling, including:
- ISO 15223-1 for medical device symbols.
- ISO 20417 for information supplied by the manufacturer.
- GS1, HIBCC or ICCBBA standards for Unique Device Identification (UDI).
- Applicable guidance published by the European Commission and the Medical Device Coordination Group (MDCG).
Manufacturers should remember that labelling is not simply a marketing or packaging activity. It forms part of the Technical Documentation reviewed during conformity assessment and must remain consistent with the device’s intended purpose, Risk Management File, Clinical Evaluation or Performance Evaluation, Instructions for Use and all claims made throughout the product’s lifecycle.
By understanding the regulatory framework at the outset, manufacturers can develop labelling that not only satisfies the legal requirements of the MDR and IVDR but also supports patient safety, product traceability and ongoing regulatory compliance.
What Information Must Be Included on Medical Device and IVD Labels?
One of the primary objectives of the EU MDR and IVDR is to ensure that anyone handling or using a medical device or IVD has access to the information necessary to identify the product, understand its intended purpose and use it safely. To achieve this, manufacturers must include specific information on the device label, packaging and, where applicable, the accompanying Instructions for Use.
The exact information required varies depending on factors such as the type of device, its intended purpose, classification and whether it is supplied sterile, reusable or intended for self-testing. However, both the MDR and IVDR require manufacturers to provide sufficient information to ensure safe use, product traceability and effective regulatory oversight.
Typical information found on compliant medical device and IVD labels includes:
- Device name and product description.
- Catalogue or reference number (REF).
- Batch number (LOT) or serial number (SN), as applicable.
- Name and address of the manufacturer.
- Name and address of the EU Authorised Representative, where required.
- CE marking and Notified Body identification number, where applicable.
- Unique Device Identification (UDI).
- Date of manufacture and/or expiry date, where appropriate.
- Storage and handling conditions.
- Sterility information and sterilisation method, where applicable.
- Single-use or reusable device identification.
- Important warnings, precautions and safety information.
- Medical device symbols compliant with ISO 15223-1.
- Information directing users to the Instructions for Use, where required.
For IVDs, additional information may also be required, including specimen type, intended testing environment, reagent preparation instructions, analytical limitations and information relating to calibration or control materials. These additional requirements help ensure that diagnostic tests are used correctly and produce reliable results.
Manufacturers should also ensure that all information presented on the label is consistent with the device’s Technical Documentation, Clinical Evaluation or Performance Evaluation, Risk Management File and Instructions for Use. Inconsistencies between these documents are commonly identified during Notified Body assessments and may result in non-conformities or delays to certification.
Ultimately, a compliant label should do more than satisfy regulatory requirements—it should enable users to identify the device quickly, understand its intended purpose and use it safely throughout its lifecycle.
Medical Device Labelling Requirements Under the EU MDR
Medical device labelling requirements under the EU Medical Device Regulation (EU MDR 2017/745) are designed to ensure that every device can be correctly identified, safely used and effectively traced throughout its lifecycle. Manufacturers must provide sufficient information to enable healthcare professionals, patients and distributors to understand the device’s intended purpose, recognise any limitations or warnings and maintain compliance with the Regulation.
The detailed requirements are contained within Annex I, Chapter III of the MDR, which forms part of the General Safety and Performance Requirements (GSPRs). The information provided must be clear, legible, indelible and presented in a way that is appropriate for the intended users of the device.
Although the exact content depends on the type of medical device, a compliant MDR label will typically include:
- The name or trade name of the device.
- Information allowing the device to be uniquely identified, such as the catalogue (REF), batch (LOT) or serial number (SN).
- The name, registered trade name or registered trademark and address of the manufacturer.
- Details of the EU Authorised Representative where the manufacturer is located outside the European Union.
- The CE marking and, where applicable, the four-digit identification number of the Notified Body.
- The Unique Device Identifier (UDI).
- The date of manufacture and expiry date where relevant.
- Any storage, transport or environmental conditions necessary to maintain device performance.
- Information relating to sterility, including the sterilisation method where applicable.
- Symbols indicating whether the device is single-use, reusable or contains hazardous substances.
- Important warnings, precautions or contraindications that are essential for safe use.
- A reference to the accompanying Instructions for Use where these are supplied separately.
The information provided on the label must also remain fully consistent with the manufacturer’s Technical Documentation, Risk Management File, Clinical Evaluation Report and Instructions for Use. Any discrepancies between these documents may be identified during conformity assessment by a Notified Body or during market surveillance activities by Competent Authorities.
Manufacturers should remember that labelling is not a one-time activity completed before CE marking. Labels must be reviewed and updated whenever changes are made to the device, its intended purpose, applicable standards or regulatory requirements. Information gathered through Post-Market Surveillance, vigilance activities or customer feedback may also necessitate revisions to labelling to maintain compliance and protect patient safety.
Ultimately, compliant MDR labelling serves as both a regulatory requirement and an essential risk control measure, helping to ensure that medical devices can be identified, handled and used safely throughout their entire lifecycle.
Need a Detailed Breakdown of EU MDR Labelling Requirements?
This guide provides an overview of medical device and IVD labelling under the MDR and IVDR. If you're looking for a detailed explanation of the specific labelling requirements contained within Annex I, Chapter III of the EU MDR, including mandatory label content, Instructions for Use, language requirements and practical compliance considerations, read our Medical Device Labelling Requirements Explained.
IVD Labelling Requirements Under the EU IVDR
The In Vitro Diagnostic Medical Devices Regulation (IVDR 2017/746) establishes comprehensive labelling requirements to ensure that IVDs can be correctly identified, safely used and accurately interpreted throughout their lifecycle. Because diagnostic devices influence clinical decision-making rather than directly treating patients, IVDR labelling places particular emphasis on providing users with the information necessary to achieve reliable and reproducible test results.
As with the MDR, the detailed labelling requirements are contained within Annex I, Chapter III of the IVDR. Manufacturers must ensure that labels, packaging and accompanying Instructions for Use provide clear, accurate and unambiguous information appropriate for the intended users, whether laboratory professionals, healthcare practitioners or members of the public using self-tests.
A compliant IVDR label will typically include:
- The name or trade name of the IVD.
- A description allowing the device to be uniquely identified.
- Catalogue (REF), batch (LOT) or serial number (SN), where applicable.
- The name and address of the manufacturer.
- Details of the EU Authorised Representative where the manufacturer is established outside the European Union.
- The CE marking and, where applicable, the four-digit identification number of the Notified Body.
- The Unique Device Identifier (UDI).
- Expiry date and date of manufacture where relevant.
- Storage and transport conditions necessary to maintain device performance.
- Information identifying whether the device is intended for professional use, near-patient testing or self-testing.
- Important warnings, precautions and limitations.
- Instructions regarding specimen type, sample collection and handling where applicable.
- Information relating to reagent preparation, calibration or control materials where required.
- Medical device symbols compliant with ISO 15223-1 and other recognised standards.
- A reference to the accompanying Instructions for Use.
Many IVDs require additional information that is not typically found on general medical devices. For example, labels may need to specify the type of specimen that can be analysed, acceptable storage temperatures for reagents, stability after opening, analytical limitations, traceability of calibrators and controls, or environmental conditions that could affect test performance. These requirements are particularly important for ensuring accurate diagnostic results and reducing the risk of incorrect clinical decisions.
As with medical devices, IVDR labelling must remain fully consistent with the manufacturer’s Technical Documentation, Performance Evaluation Report, Risk Management File and Instructions for Use. Any inconsistencies may be identified during conformity assessment or post-market inspections and can result in non-conformities, certification delays or regulatory action.
Manufacturers should also recognise that labelling is an evolving component of regulatory compliance. Changes arising from Post-Market Performance Follow-up (PMPF), Post-Market Surveillance (PMS), vigilance reporting, updated harmonised standards or revised regulatory guidance may all require labels to be reviewed and updated throughout the lifetime of the device.
Ultimately, compliant IVDR labelling helps ensure that diagnostic devices are correctly identified, appropriately used and capable of delivering reliable results while supporting patient safety, product traceability and ongoing regulatory compliance.
Instructions for Use (IFUs)
While the device label provides essential identification and safety information, the Instructions for Use (IFU) provide the detailed guidance necessary to ensure that a medical device or IVD can be used safely and effectively throughout its intended lifecycle. Under both the EU MDR and IVDR, manufacturers must determine whether an IFU is required and, where one is provided, ensure that it contains comprehensive information appropriate for the intended users.
The MDR and IVDR recognise that the amount of information that can be displayed on a product label is limited. The IFU therefore supplements the label by providing detailed instructions on installation, operation, maintenance, cleaning, storage, disposal and any precautions necessary to reduce risks associated with the device.
For many devices, providing an IFU is mandatory. However, certain low-risk medical devices may not require one where the device can be used safely and as intended without additional instructions. Manufacturers must carefully justify any decision not to supply an IFU as part of their Risk Management process and Technical Documentation.
A well-prepared IFU will typically include:
- The device’s intended purpose and intended users.
- A description of the device and its principal functions.
- Contraindications, warnings and precautions.
- Step-by-step instructions for safe use.
- Installation, assembly or setup instructions where applicable.
- Storage, transport and environmental conditions.
- Cleaning, disinfection and maintenance procedures for reusable devices.
- Information relating to calibration or performance checks where required.
- Instructions for troubleshooting common issues.
- Device disposal requirements.
- An explanation of any symbols used on the label or packaging that may not be immediately understood by users.
For IVDs, the IFU often contains additional information that is critical to obtaining accurate diagnostic results. This may include specimen collection procedures, reagent preparation, calibration methods, quality control requirements, interpretation of results, analytical limitations, interfering substances and guidance on handling invalid or inconclusive results.
Manufacturers should ensure that the information presented within the IFU remains fully aligned with the product label, Technical Documentation, Clinical Evaluation or Performance Evaluation, Risk Management File and all marketing claims. Inconsistencies between these documents are a common finding during Notified Body audits and Competent Authority inspections.
Electronic Instructions for Use (eIFUs) may also be used for certain categories of devices where permitted under applicable legislation. Manufacturers choosing to provide electronic instructions must comply with the relevant regulatory requirements, ensure users can easily access the information and maintain appropriate controls for document version management and availability throughout the device lifecycle.
Ultimately, the IFU should not be viewed simply as a regulatory document. It is a key risk control measure that helps ensure users understand how to operate the device safely, achieve the intended clinical or diagnostic performance and minimise the likelihood of misuse or user error.
Unique Device Identification (UDI)
The Unique Device Identification (UDI) system is one of the most significant changes introduced by both the EU Medical Device Regulation (EU MDR 2017/745) and the In Vitro Diagnostic Medical Devices Regulation (IVDR 2017/746). Its purpose is to improve product traceability, strengthen patient safety and support more effective Post-Market Surveillance, vigilance reporting and market surveillance activities across Europe.
Every medical device and IVD subject to the MDR or IVDR must be assigned a Unique Device Identifier unless a specific exemption applies. The UDI enables regulators, healthcare providers, distributors and manufacturers to identify individual devices quickly and accurately throughout the supply chain and during their operational lifetime.
The UDI consists of two components:
- UDI-DI (Device Identifier) – the fixed portion that identifies the manufacturer and the specific model or version of the device.
- UDI-PI (Production Identifier) – the variable portion that identifies production information such as the batch number, serial number, manufacturing date or expiry date where applicable.
Both elements are typically presented in a human-readable format alongside a machine-readable barcode or data carrier, allowing devices to be scanned efficiently during manufacturing, distribution, clinical use and post-market activities.
Under the MDR and IVDR, the UDI must appear on the device label and, where applicable, on all higher levels of packaging. Certain reusable devices must also bear a permanent UDI directly on the device itself if required by the Regulation.
The UDI system supports several important regulatory objectives, including:
- Improving product traceability throughout the supply chain.
- Supporting efficient product recalls and Field Safety Corrective Actions (FSCAs).
- Facilitating incident reporting and vigilance investigations.
- Helping healthcare organisations manage inventory and procurement.
- Reducing the risk of device misidentification.
- Supporting the registration of devices within EUDAMED.
- Strengthening transparency across the European medical device market.
Manufacturers are responsible for assigning UDIs in accordance with an organisation designated by the European Commission, such as GS1, HIBCC or ICCBBA. They must also ensure that UDI information remains accurate and is updated whenever changes are made that require a new Device Identifier.
Although implementing UDI can initially appear complex, it has become a fundamental component of regulatory compliance under both the MDR and IVDR. A well-managed UDI system not only satisfies legal requirements but also improves supply chain efficiency, facilitates market surveillance and enhances patient safety by ensuring that every device can be rapidly identified and traced throughout its lifecycle.
Need to Understand Medical Device UDI?
This guide explains how UDI fits into medical device and IVD labelling under the MDR and IVDR. If you're looking for a complete introduction to Unique Device Identification, including UDI-DI, UDI-PI, issuing agencies, EUDAMED requirements, implementation steps and common compliance challenges, read our Medical Device UDI for Beginners Guide.
Medical Device Symbols and ISO 15223-1
Medical device labels often contain a wide range of internationally recognised symbols that communicate important information quickly and consistently, regardless of the user’s language. The use of standardised symbols helps reduce the amount of text required on labels while improving clarity for healthcare professionals, distributors and patients across different countries.
The principal international standard governing medical device symbols is ISO 15223-1: Medical devices — Symbols to be used with information to be supplied by the manufacturer. This standard specifies hundreds of recognised symbols that manufacturers may use on medical device and IVD labels, packaging and Instructions for Use to communicate regulatory, safety and product information.
Using standardised symbols offers several important advantages. They improve international consistency, reduce translation requirements, minimise the risk of misinterpretation and help manufacturers comply with the multilingual labelling obligations of both the MDR and IVDR. Many of these symbols are now widely recognised throughout the global medical device industry.
Some of the most commonly used symbols include:
| Symbol | Meaning |
|---|---|
| CE | CE marking indicating conformity with applicable European legislation. |
| UDI | Unique Device Identifier. |
| REF | Catalogue or reference number. |
| LOT | Batch number. |
| SN | Serial number. |
| Manufacturer | Identifies the legal manufacturer of the device. |
| EC REP | EU Authorised Representative. |
| Use-by Date | Expiry date of the device or reagent. |
| Date of Manufacture | Manufacturing date. |
| Consult Instructions for Use | Indicates that users should read the accompanying IFU. |
| Do Not Re-use | Device intended for single use only. |
| Sterile | Indicates that the device has been supplied sterile. |
| Temperature Limits | Permitted storage or operating temperature range. |
| Keep Dry | Protect the product from moisture. |
| Fragile | Indicates that care should be taken during transport and handling. |
Manufacturers should only use symbols that are recognised by applicable standards or accepted regulatory guidance. Introducing custom or non-standard symbols can create confusion for users and may lead to regulatory non-conformities during Notified Body assessments or Competent Authority inspections.
It is equally important that every symbol used on the label is explained where necessary within the Instructions for Use, particularly if the meaning may not be immediately understood by the intended users. Manufacturers should also ensure that symbols are reproduced accurately and consistently across all packaging levels, electronic documentation and marketing materials.
As standards continue to evolve, manufacturers should periodically review their labelling to ensure it reflects the latest edition of ISO 15223-1 and any updated guidance issued by regulators. Regular reviews help maintain compliance while ensuring users continue to receive clear, accurate and internationally recognised information.
Are Your Medical Device Labels Still Compliant?
This article introduces the role of symbols in medical device and IVD labelling. To learn about the latest changes introduced in ISO 15223-1:2025, including the new EU REP symbol, updated symbol requirements and how to avoid common audit findings, read our Guide to ISO 15223-1:2025.
Common Medical Device and IVD Labelling Mistakes
Even manufacturers with well-developed Quality Management Systems can encounter labelling issues during internal audits, Notified Body assessments or Competent Authority inspections. In many cases, the device itself fully complies with the applicable regulatory requirements, but deficiencies in the labelling can delay certification, prevent market access or result in corrective actions.
Labelling should never be considered a standalone activity completed at the end of product development. It must remain closely aligned with the manufacturer’s Technical Documentation, Risk Management File, Clinical Evaluation or Performance Evaluation, Instructions for Use and regulatory strategy throughout the entire product lifecycle.
Some of the most common labelling mistakes include:
Missing Mandatory Information
One of the most frequent non-conformities is the omission of information required under Annex I, Chapter III of the MDR or IVDR. Missing manufacturer details, expiry dates, UDI information, storage conditions or required warnings can all result in regulatory findings.
Inconsistent Information Across Documentation
The information presented on the product label should always match the Technical Documentation, Instructions for Use, Clinical Evaluation or Performance Evaluation, Risk Management File and Declaration of Conformity. Differences between these documents are commonly identified during conformity assessments.
Incorrect or Outdated Symbols
Manufacturers occasionally continue using obsolete symbols or apply symbols incorrectly. Symbols should comply with the latest version of ISO 15223-1 where applicable and be used consistently across labels, packaging and accompanying documentation.
Poor Label Legibility
Information that is difficult to read because of small font sizes, poor colour contrast, overcrowded layouts or low print quality may compromise safe use of the device. Labels should remain clear and legible throughout the product’s expected lifetime.
Inadequate Translation and Language Management
The MDR and IVDR require information to be supplied in the language(s) specified by each Member State in which the device is made available. Poor translations or incomplete language versions can create safety risks and lead to regulatory non-conformities.
Failure to Update Labels
Manufacturers sometimes overlook the need to revise labels following design changes, updated standards, Post-Market Surveillance findings, vigilance activities or changes to regulatory requirements. Label artwork should form part of the manufacturer’s formal change control process to ensure it remains current throughout the device lifecycle.
Incorrect UDI Implementation
Errors in assigning, formatting or displaying the Unique Device Identifier are another common issue. Manufacturers should ensure that UDI information is accurate, consistent and correctly represented in both human-readable and machine-readable formats.
Unsupported Claims
Every statement made on the label must be supported by objective evidence within the Technical Documentation. Marketing claims that extend beyond the device’s intended purpose or are not supported by Clinical Evaluation or Performance Evaluation evidence may attract regulatory scrutiny.
Avoiding these common mistakes requires more than simply reviewing the label artwork before production. Effective label management should be integrated into the manufacturer’s Quality Management System, with documented review procedures, version control, change management and verification processes to ensure that labelling remains accurate, compliant and consistent throughout the product lifecycle.
Maintaining Compliant Medical Device and IVD Labels Throughout the Product Lifecycle
Achieving compliant labelling is not the end of the regulatory process. Throughout the lifetime of a medical device or IVD, manufacturers are responsible for ensuring that labels, packaging and Instructions for Use remain accurate, up to date and fully aligned with the latest regulatory requirements, product information and post-market evidence.
Under both the EU MDR and IVDR, labelling forms part of the manufacturer’s Technical Documentation and Quality Management System. Any changes affecting the device, its intended purpose, performance or regulatory status should trigger a review of all associated labelling to confirm that the information supplied to users remains correct.
Manufacturers should review their labelling whenever there are changes to:
- The intended purpose of the device.
- Device design or specifications.
- Manufacturing processes or materials.
- Clinical Evaluation or Performance Evaluation findings.
- Risk Management documentation.
- Post-Market Surveillance (PMS) or Post-Market Performance Follow-up (PMPF) results.
- Vigilance reports or Field Safety Corrective Actions (FSCAs).
- Applicable harmonised standards or common specifications.
- Regulatory guidance published by the European Commission or the Medical Device Coordination Group (MDCG).
- Company details, Authorised Representative information or UDI data.
An effective Quality Management System should include documented procedures governing the creation, review, approval and revision of label artwork. Version control, document approval workflows and formal change management help ensure that only the latest approved labels are released for production and that obsolete versions cannot be used inadvertently.
Manufacturers should also verify that information remains consistent across all regulatory documentation, including the device label, packaging, Instructions for Use, Technical Documentation, Risk Management File, Clinical Evaluation or Performance Evaluation, Declaration of Conformity and marketing materials. Maintaining this consistency reduces the risk of regulatory findings during audits and helps ensure users always receive accurate information.
Regular internal audits of labelling processes can identify issues before they become compliance problems. These reviews should assess not only the content of the labels themselves but also the effectiveness of document control procedures, translation management, artwork approval processes and compliance with applicable standards such as ISO 15223-1 and ISO 20417.
Ultimately, compliant labelling should be viewed as a continuous process rather than a one-time regulatory exercise. By integrating label management into the broader Quality Management System and maintaining robust review procedures, manufacturers can support patient safety, improve product traceability and demonstrate ongoing compliance with the EU MDR and IVDR throughout the entire product lifecycle.
Conclusion
Medical device and IVD labelling is a fundamental component of regulatory compliance under the EU MDR and IVDR. Far more than simply identifying a product, compliant labelling enables healthcare professionals, laboratory personnel and patients to use devices safely, supports product traceability through the Unique Device Identification (UDI) system and provides regulators with the information needed to oversee products throughout their lifecycle.
Manufacturers must ensure that labels, packaging and Instructions for Use contain all mandatory information required by Annex I, Chapter III of the applicable Regulation while remaining fully consistent with the Technical Documentation, Risk Management File, Clinical Evaluation or Performance Evaluation and Quality Management System. Compliance also requires the correct use of recognised standards, including ISO 15223-1 for symbols and ISO 20417 for information supplied by the manufacturer.
As regulatory requirements continue to evolve, maintaining compliant labelling is an ongoing responsibility rather than a one-off exercise. Regular reviews, effective document control and robust change management processes help ensure that labels remain accurate, support patient safety and continue to meet the expectations of Notified Bodies and Competent Authorities.
Whether you are developing a new medical device, preparing an IVD for CE marking or updating existing product artwork, investing time in compliant labelling will help reduce regulatory risk, facilitate market access and strengthen confidence in your products throughout their entire lifecycle.
How Patient Guard Can Help
At Patient Guard, we understand the complexities of medical device labelling under the EU MDR and IVDR. Our expert team offers tailored services to help manufacturers develop compliant labels and IFUs, from gap analyses and content development to usability testing and Notified Body submissions. We ensure your labelling meets regulatory requirements and enhances user safety.
Patient Guard also supports manufacturers with:
- Medical device label reviews and compliance assessments.
- Instructions for Use (IFU) preparation and review.
- ISO 15223-1 symbol selection and implementation.
- Unique Device Identification (UDI) implementation.
- Technical Documentation preparation and review.
- UKCA and CE marking regulatory support.
- Gap analyses against EU MDR, UK MDR and IVDR labelling requirements.
- Ongoing regulatory support following product or labelling changes.
Frequently Asked Questions About Medical Device Labelling
Medical device labels typically include the manufacturer’s details, device name, catalogue number, batch or serial number, UDI, expiry date where applicable, storage conditions, warnings, regulatory symbols and other information necessary for the safe and effective use of the device.
A Unique Device Identifier (UDI) is a globally recognised identification system that improves the traceability of medical devices. It consists of a Device Identifier (UDI-DI) and a Production Identifier (UDI-PI), helping manufacturers and regulators identify products throughout their lifecycle.
Not always. The EU MDR allows certain low-risk devices to be supplied without printed Instructions for Use where the device can be used safely without them. However, manufacturers must be able to justify this decision and comply with applicable regulatory requirements.
Yes. Electronic Instructions for Use may be used for certain categories of medical devices where permitted by legislation, provided manufacturers meet the applicable accessibility and usability requirements.
ISO 15223-1 is the international standard that specifies symbols used on medical device labels, packaging and accompanying information. Using recognised symbols improves consistency, supports international trade and helps reduce language barriers.
Yes. Medical device labels and Instructions for Use must generally be provided in the language(s) required by the country where the device is marketed. Manufacturers should verify the specific language requirements for each jurisdiction.
The device label provides essential identification and safety information directly on the device or its packaging, while the Instructions for Use contain more detailed information about installation, operation, maintenance, warnings and safe use.
Non-compliant labelling may result in regulatory findings, delays to market approval, product recalls, Field Safety Corrective Actions (FSCAs) or enforcement action by the relevant Competent Authority.
Although many requirements remain similar, there are important differences between the EU MDR and UK Medical Devices Regulations, including references to CE marking, UKCA marking, UK Responsible Persons and EU Authorised Representatives. Manufacturers supplying both markets should ensure their labelling complies with the applicable legislation.
Yes. Patient Guard provides expert support with medical device labelling, Instructions for Use, ISO 15223-1 symbols, UDI implementation, Technical Documentation and regulatory compliance for manufacturers placing devices on the UK and EU markets.
References
This guide is based on the following legislation, international standards and official regulatory guidance relating to medical device labelling under the European Medical Devices Regulation (MDR) and international regulatory frameworks.
| Organisation | Reference | Why it's relevant |
|---|---|---|
| European Union | Regulation (EU) 2017/745 on Medical Devices (MDR) | Defines the legal requirements for medical device labelling through the General Safety and Performance Requirements (Annex I) together with the Unique Device Identification (UDI) and information supplied by the manufacturer requirements set out in Annex VI. |
| International Organization for Standardization (ISO) | ISO 15223-1:2021 – Medical Devices – Symbols to Be Used with Information to Be Supplied by the Manufacturer – Part 1: General Requirements | Defines the internationally recognised symbols used on medical device labels, packaging and Instructions for Use, helping manufacturers communicate essential safety and regulatory information consistently across global markets. |
| International Organization for Standardization (ISO) | ISO 20417:2026 – Medical Devices – Information to Be Supplied by the Manufacturer | Specifies the general requirements for information supplied by the manufacturer, including device labels, packaging, markings and accompanying documentation such as Instructions for Use. It provides the framework for communicating essential safety, performance and identification information and complements ISO 15223-1 by defining what information must be supplied rather than how it is presented. |
| European Union | Commission Implementing Regulation (EU) 2025/1234 on Electronic Instructions for Use (eIFU) | Amends Implementing Regulation (EU) 2021/2226 by expanding the categories of medical devices for which Instructions for Use may be provided in electronic form. It establishes the current European regulatory framework governing the use of electronic IFUs, including requirements for accessibility, availability, risk assessment and ongoing compliance. |
| European Commission | Unique Device Identifier (UDI) | Explains the European Commission's Unique Device Identification (UDI) system, including UDI carrier requirements, device traceability and labelling obligations under the MDR. |
| U.S. Food and Drug Administration (FDA) | General Device Labeling Requirements | Provides the FDA's medical device labelling requirements under 21 CFR Part 801, including manufacturer identification, intended use, warnings and other mandatory label content for devices marketed in the United States. |
| European Commission | MDCG Endorsed Documents and Other Guidance | Provides official Medical Device Coordination Group guidance supporting the implementation of MDR labelling requirements, including guidance relating to UDI, symbols, Instructions for Use and information supplied by the manufacturer. |
Medical device labelling requirements continue to evolve through legislation, recognised standards and regulatory guidance. Manufacturers should always consult the latest published legislation, international standards and official guidance when designing, reviewing and maintaining compliant device labels, electronic Instructions for Use and accompanying information.
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