Introduction
Medical device labelling is a critical component of regulatory compliance and user safety. Whether it’s the packaging of a syringe, the user manual for a surgical robot, or the software instructions for a wearable device, labelling provides essential information to ensure proper use, reduce risk, and support traceability.
This article explores the purpose of medical device labelling, key regulatory requirements, international standards, and best practices for manufacturers.
What is medical device labelling?
In regulatory terms, medical device labelling refers not only to the physical label affixed to a product but also to any written, printed, or graphic information associated with the device.
Labelling includes:
- Labels on the device or packaging
- Instructions for use (IFU)
- User manuals
- Implant cards
- Digital labels or electronic IFU (eIFU)
Labelling serves as the primary means of communication between the manufacturer and the end user, whether that user is a clinician, patient, or caregiver. Its primary goals are:
- To identify the device and manufacturer
- To provide essential information for safe and effective use
- To support correct storage, handling, and maintenance
- To communicate warnings, precautions, and contraindications
- To enable traceability (e.g. lot/batch numbers, unique device identifiers)
Why is labelling critical?
Improper, unclear, or missing labelling can lead to:
- Misuse of the device
- Medical errors
- Harm to patients or users
- Regulatory non-compliance
- Recalls and legal liability
Medical device labelling regulations and standards
Regulatory agencies and standards bodies worldwide have developed detailed requirements for medical device labelling to protect public health. A comprehensive list of regulations and guidance documents can be found at the end of the article (see Resources).
Efforts such as IMDRF’s UDI guidance aim to harmonise labelling and traceability requirements across regions.
The Medical Device Regulation (EU 2017/745 - MDR) and in vitro Diagnostic Medical Device Regulation (EU 2017/746 - IVDR) lay down labelling requirements for devices marketed in Europe.
- MDR Annex I, Chapter III detail the labelling rules for medical devices.
Key requirements include:
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The device must bear the CE mark as proof of conformity.
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Labelling must include:
- Manufacturer’s name and address
- Unique Device Identifier (UDI)
- Device name and intended purpose
- Warnings or precautions
- Sterilisation method (if applicable)
- Date of manufacture or expiry date
- Storage and handling conditions
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Electronic IFUs (eIFUs) are permitted for certain devices under specific conditions (see Medical Device IFUs for further information)
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Language: Labelling must be provided in at least one of the official EU languages of the Member States where the device is sold. The languages chosen will depend on the product’s commercialisation plan.
While EU regulations set a baseline for labelling requirements, manufacturers must also navigate national variations in labelling requirements, particularly for language, origin, and specific product categories, to ensure compliance across the EU market.
The U.S. Food and Drug Administration (FDA) regulates medical device labelling under 21 CFR Part 801. Labelling must include:
- Manufacturer name and place of business
- Intended use
- Directions for use
- Warnings or contraindications
There are special provisions for implants, over-the-counter devices, sterile devices, single-use devices and restricted devices.
Most devices must carry a Unique Device Identifier (UDI) (21 CFR 801 Subpart B).
Canada: Health Canada Medical Devices Regulations require:
- Labelling in English and French
- Identification of manufacturer
- Device name and identifier
- Instructions for use
- Warnings and precautions
- Storage and handling conditions
- Patient implant cards for implantable devices
Australia (TGA): Labelling requirements under Therapeutic Goods (Medical Devices) Regulations 2002; UDI implementation underway.
Japan (PMDA): Medical device labelling must comply with Pharmaceutical and Medical Device Act (PMD Act), including Japanese language requirements.
China (NMPA): Labelling requirements under Medical Device Supervision and Administration Regulation, with mandatory Chinese language labelling.
International standards provide detailed guidance on labelling content, format, and symbols.
- ISO 15223-1:2021 — Medical devices — Symbols to be used with medical device labels: This standard defines internationally recognised symbols that can replace text, helping reduce translation needs and improve universal understanding.
- ISO 20417:2021 — Medical devices — Information to be supplied by the manufacturer: This standard harmonises with ISO 13485 and other regulatory requirements and provides a comprehensive checklist of the information that manufacturers must supply, covering labels, packaging markings and IFU content.
- IEC 62366-1 — Usability Engineering: While not a labelling standard per se, this standard requires manufacturers to consider how labelling and instructions support safe use as part of their usability engineering process.
- GS1 Standards — Unique Device Identification: GS1 standards are widely used for encoding UDI in barcodes and RFID tags, helping with traceability and post-market surveillance.
Best practices in medical device labelling
Electronic labelling (e-labelling or eIFU) is increasingly permitted or under consideration in many jurisdictions, including the EU, US, and Australia, particularly for certain types of devices. This approach offers benefits such as cost savings, easier updates to information, and a reduced environmental impact. However, it also presents challenges: manufacturers must ensure all users can access the information easily, and printed copies must still be provided upon request. The form of electronic delivery can also vary depending on the nature of the device. It is important for manufacturers to stay up to date with regulatory developments, as many authorities are consulting with industry and gradually introducing e-labelling requirements for specific device categories.
Focus on usability in medical device labelling, as poorly designed labelling is a known source of user and use errors. Regulators increasingly expect manufacturers to validate labelling as part of their usability engineering processes. To support this, incorporate human factors by evaluating how users interact with labelling, considering font size, contrast, placement, and readability under various conditions. Manufacturers should design for clarity by using clear, unambiguous language and applying consistent terminology across labels, instructions for use (IFU), and marketing materials. Manufacturers should also plan for translation as part of their development timelines, using professional medical translators and accounting for regional dialects or language variations to ensure accuracy and relevance in all target markets. Where appropriate, using standardised symbols, such as those defined in ISO 15223-1, can help support international use and reduce the need for translation.
UDI (Unique Device Identification) implementation has become a regulatory requirement in many key markets, including the United States, European Union, China, and others. The introduction of UDI systems is intended to enhance the identification and traceability of medical devices throughout their lifecycle. By assigning a unique identifier to each device, manufacturers, distributors, healthcare providers, and regulators can improve supply chain transparency, reduce the risk of counterfeit products, and facilitate more efficient recalls when necessary. In addition, UDI plays a critical role in post-market vigilance by enabling better tracking of device performance, supporting adverse event reporting, and improving the accuracy of data in registries and health records. Manufacturers must ensure that UDI information is correctly applied to device labelling and packaging, and, where required, submitted to the relevant regulatory databases, such as the FDA’s GUDID in the US or EUDAMED in the EU.
Documentation and change control: Labelling is a critical component of the technical documentation for medical devices. It should be managed as a controlled document within the quality management system (QMS), following standards such as ISO 13485 and 21 CFR 820. This ensures that any changes to labelling are correctly documented, reviewed, and approved, maintaining consistency and compliance throughout the product lifecycle. Staying up to date with regulatory changes is equally important, as labelling requirements continue to evolve, particularly with the increasing adoption of e-labelling solutions and the expansion of UDI systems across jurisdictions. Continuous monitoring of these updates helps ensure that labelling remains compliant and fit for purpose.
Conclusion
Medical device labelling is far more than just a sticker on a product. It is a critical safety and regulatory tool that supports proper use, reduces risks, and enables traceability throughout the device’s lifecycle. As global regulations and standards evolve, manufacturers must stay vigilant, adopting best practices and harmonised approaches to ensure their labelling meets all applicable requirements.
By prioritising clear, compliant, and user-friendly labelling, medical device companies can not only meet regulatory obligations but also enhance the safety and satisfaction of patients and healthcare professionals.
Resources
European Union Medical Device Coordination Group (MDCG)
- MDCG 2021-26 – Guidance on classification of IVDs (includes labelling elements)
- MDCG 2019-9 – Summary of safety and clinical performance (labelling considerations)
- MDCG 2018-1 – UDI guidance
U.S.A Food and Drug Administration
- FDA Labeling Requirements - Device Advice
- FDA Guidance – Device Labeling
- FDA Guidance – Unique Device Identification (UDI)
Health Canada
- Guidance on Labelling of Medical Devices (GUI-0016)
- Guidance for the Labelling of In Vitro Diagnostic Devices
Australia Therapeutic Goods Administration (TGA)
U.K. Medicines and Healthcare products Regulatory Agency (MHRA)
- MHRA guidance on labelling requirements for medical devices
- MHRA guidance on UDI and device traceability
International Medical Device Regulators Forum (IMDRF)
European Union MDR/IVDR
- MDR (EU) 2017/745, Annex I, Chapter III – Requirements regarding the information supplied with the device
- IVDR (EU) 2017/746, Annex I, Chapter III – Requirements regarding the information supplied with the device
- Commission Regulation (EU) No 207/2012 on electronic instructions for use of medical devices
U.S.A Food and Drug Administration
- 21 CFR 801 – Labeling requirements for medical devices
- 21 CFR 809 – Labeling requirements for in vitro diagnostic products
Health Canada
Australia Therapeutic Goods Administration (TGA)
U.K. Medicines and Healthcare products Regulatory Agency (MHRA)
Japan (PMDA): Medical device labelling must comply with Pharmaceutical and Medical Device Act (PMD Act), including Japanese language requirements.
China (NMPA): Labelling requirements under Medical Device Supervision and Administration Regulation, with mandatory Chinese language labelling.
International Standards
- ISO 15223-1:2021 — Medical devices — Symbols to be used with medical device labels: This standard defines internationally recognised symbols that can replace text, helping reduce translation needs and improve universal understanding.
- ISO 20417:2021 — Medical devices — Information to be supplied by the manufacturer: This standard harmonises with ISO 13485 and other regulatory requirements and provides a comprehensive checklist of the information that manufacturers must supply, covering labels, packaging markings and IFU content.
- IEC 62366-1 — Usability Engineering: While not a labelling standard per se, this standard requires manufacturers to consider how labelling and instructions support safe use as part of their usability engineering process.
- GS1 Standards — Unique Device Identification: GS1 standards are widely used for encoding UDI in barcodes and RFID tags, helping with traceability and post-market surveillance.
CE Marking: A certification mark that indicates conformity with health, safety, and environmental protection standards for products sold within the European Economic Area (EEA).
Competent Authority (CA): A national regulatory body responsible for regulating and overseeing the safety, efficacy, and quality of medical devices within its jurisdiction. Also see Regulatory Authority.
Compliance: Adherence to regulations, standards, and guidelines set forth by regulatory authorities.
Conformity Assessment: A process used to determine whether a product, service, system, or entity meets specified standards, regulations, or requirements.
FDA Approval: The process by which the U.S. Food and Drug Administration (FDA) officially recognises that a medical device is safe and effective for its intended use.
Harmonisation: The process of aligning standards, requirements, and procedures across different jurisdictions to ensure consistent safety and efficacy evaluations and market access for medical devices.
Healthcare Professional: An individual trained and licensed to provide medical care, treatment, and advice to patients, encompassing a range of roles such as physicians, nurses, pharmacists, and allied health professionals.
Healthcare Provider: An individual or organisation licensed or otherwise authorised to deliver medical, nursing, dental, or other healthcare services to patients or clients.
Human-Device Interaction: The interaction between the user and the medical device, including how the user perceives, interprets, and responds to the device’s signals and controls.
Human Factors Engineering (HFE): The application of knowledge about human abilities, limitations, and other characteristics to the design of medical devices, systems, and environments to ensure safe, comfortable, and effective use. Also see Usability Engineering.
Indication of Use: A concise statement specifying the medical conditions or purposes for which the medical device is intended to be used, as approved by regulatory authorities.
Instructions for Use (IFU): The document provided by the manufacturer that includes essential information on a medical device’s intended purpose, proper handling, operation, maintenance, and safety precautions for users.
Intended purpose: The use for which a medical device is intended according to the information provided by the manufacturer on the labelling, in the instructions for use (IFU), or in promotional materials. This may also be referred to as the Intended Use in some jurisdictions. Also see Indication of Use.
International Medical Device Regulators Forum (IMDRF): A global regulatory collaboration focused on harmonising medical device regulations to facilitate patient access to safe and effective devices. This organisation was formerly the Global Harmonization Task Force (GHTF).
in vitro Diagnostics (IVD): Medical tests conducted on samples taken from the human body, such as blood or tissue, to detect diseases, conditions, or infections outside the body.
ISO 13485: An international standard that specifies requirements for a quality management system (QMS) specific to the medical devices industry.
Labelling: The label on a medical device and all descriptive and informational literature associated with the device. Also see Instructions for Use (IFU)
Manufacturer: A legal entity that designs, produces, assembles, or labels a medical device with the intention of placing it on the market.
Notified Body (NB): An organisation designated by a country authority to assess the conformity of certain products before being placed on the market, ensuring they meet applicable regulatory requirements and standards.
Quality Management System (QMS): A formalised system that documents the structure, responsibilities, and procedures required to achieve effective quality management.
Regulation: The rules, laws, standards, and requirements set by regulatory authorities to ensure the safety, efficacy, and quality of devices intended for medical use.
Regulatory Authority: An official body overseeing and enforcing laws, regulations, and standards within a specific industry or sector to ensure compliance and protect public interests. Also known as a Regulatory Authority. Also see Competent Authority and Notified Body.
Regulatory Submission: The formal process of submitting documentation and data to regulatory authorities for review and approval to market or sell the device within a specific jurisdiction.
Safety: The condition of being protected from or unlikely to cause danger, risk, or injury.
Standard: A document that provides guidance, requirements, or specifications established by regulatory bodies, industry organisations, or international consensus groups.
Sterilisation: A process designed to destroy all microbial life, including spores, on a medical device.
Technical Documentation: All documents that demonstrate the design, manufacture, and performance of the device, essential for ensuring compliance with regulatory requirements. This is also known as the Technical File.
Unique Device Identification (UDI): A system that marks and identifies medical devices within the healthcare supply chain.
Universal Health Coverage (UHC): Ensuring all individuals and communities receive the necessary health services without suffering financial hardship.
Usability Engineering: The process of designing medical devices to ensure they are safe, effective, and easy to use by intended users under specified conditions.
Usability Testing: The evaluation of a medical device by testing it with real users to identify usability issues and improve the design.
Use Environment: The settings and conditions under which a medical device is used, such as hospitals, clinics, or home settings.
Use Error: Errors that occur during the use of a device due to poor design, leading to incorrect operation by the user.
Use Scenario: A detailed narrative describing the sequence of actions that a user would take to complete a task with the medical device in a specific context.
User: Any individual who operates or interacts with a medical device, including healthcare professionals, patients, and caregivers.
User Requirements: The requirements and preferences of the intended users, which must be considered and addressed in the device design. Also known as User Needs or Customer Specifications.
Validation: Confirmation by examining and providing objective evidence that the particular requirements for a specific intended use can be consistently fulfilled.