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Medical Device Labelling

Medical Device Labelling

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    Under the new EU MDR, all medical devices must be labeled in accordance with the EU MDR medical device labelling requirements. Labels must include the device name, model number, serial number, manufacturer name and address, CE mark, any applicable warnings and instructions for use, the date of manufacture, and the batch number. Labels must also include a unique device identifier (UDI) which is assigned to each device when it is released onto the market. The UDI should be applied to the label, instructions for use, and the device packaging.

    Medical device symbols should be represented in all medical device labelling and packaging material. Medical device symbols is a significant regulatory requirements followed in every medical device regulation. EU MDR 2017/745 has new requirements that looks for various kinds of medical device symbols to be indicated on the medical device labelling. Medical device symbols creates a necessity to translate the information provided on the labels into multiple languages, depending on where the device is made available. This requirement can be dealt with by using medical device symbols. The use of medical device symbols on the label as an alternative to written language is mentioned in GSPR of EU MDR in 23.1. (h), as medical device symbols are efficient, cost saving and internationally understood concepts to convey the required information to the user of a medical device.

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    The medical device labelling requirements for medical devices according to the EU MDR are as follows:

    • The labels must include the name and address of the manufacturer or, if applicable, the authorized representative.
    • The medical device labels must include the CE marking and, where applicable, the number of the notified body.
    • The medical device labels must include the device’s name, model or catalogue number, and where applicable, other identifying information.
    • The medical device labelling must include the name, strength and quantity of any active substances contained in the device.
    • The labels must include the device’s intended purpose.
    • The labels must include any warnings or precautions for the use of the device.
    • The medical device labelling must include any special storage or disposal instructions.
    • The medical device labelling must include the shelf life or expiry date.
    • The labels must include the date of manufacture or date of the most recent update of the device.
    • The labels where possible must include instructions for use.

    Harmonized Standards applicable to Medical device symbols are

    • EN ISO 15223-1:2021: Medical devices Symbols to be used with medical device labels, labeling, and information to be supplied – Part 1: General requirements.
    • EN 1041:2008: Information supplied by the manufacturer of medical devices.
    • EN 15986:2011: Requirements for labeling of medical devices containing phthalates.
    • EN ISO 3826-2:2008: Plastics collapsible containers for human blood and blood components – Part 2: Graphical symbols for use on labels and instruction leaflets.

    According to GSPR in chapter III where 23 b) and c) describe the following points,

    • The information required on the label shall be provided on the device itself. If this is not practicable or appropriate, some or all of the information may appear on the packaging for each unit, and/or on the packaging of multiple devices.
    • It also said that labels shall be provided in human-readable format and may be supplemented by machine-readable information such as bar codes or radio-frequency identification (RFID).

    For more information visit : Medical device symbols and labelling

    Some of the newly added medical device symbols mentioned in ISO 15223-1:2016 which should be addressed on the label as per Annex I of EU MDR are mentioned below along with their MDR clauses:

    International Symbol Corresponding GSPR Clause
    md 23.2 q) An indication that the device is a medical device. If the device is intended for clinical investigation only, the words ‘exclusively for clinical investigation’;
    bio 23.2 e) where applicable, an indication that the device contains or incorporates:

    • a medicinal substance, including a human blood or plasma derivative,
    • tissues or cells, or their derivatives, of human origin,
    • tissues or cells of animal origin, or their derivatives,
    3 23.2 e) Indicates a medical device that contains substances that can be carcinogenic, mutagenic, toxic to reproduction (CMR), or substances with endocrine disrupting properties
    vh 23.2 l) if the device is supplied sterile, an indication of its sterile state and the sterilization method;
    translate MDR Article 16 Point 3
    man Indicates a medical device that may be used multiple times (multiple procedures) on a single patient

    Medical Device Labeling

    Medical device labeling is an information supplied by the manufacturer that is associated with or affixed with a medical device or container and wrappers for the correct and safe use of a device by the intended user.

    This means a medical device label could actually be:

    • Marketing materials like leaflets and brochures
    • Product packaging
    • Product descriptions
    • User manuals (commonly called IFU – Instructions For Use)
    • Safety instructions
    • Accompanying software
    • Any document which explains how a medical machine works or how it is used
    • You might also need to translate documents like patent applications, applications for regulatory approval, patient information sheets, clinical trial forms and more.

    EU MDR- Annex – I, Chapter III, 23. Label and instruction for use 23.2 – Information on Label- provides stringent requirements for medical device labeling. The legislative References regarding the medical device labeling in context to EU MDR 2017/745 under Annex I, chapter III, 23.1 & 23.2 – Information on the label shall bear following particulars mentioned in the below medical device labeling template.

    Medical-Device-Labeling

    For more information on medical device symbols and labelling, please click this link

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    FAQ:

    • EN ISO 15223-1:2012: Medical devices Symbols to be used with medical device labels, labeling, and information to be supplied – Part 1: General requirements.
    • EN 1041:2008: Information supplied by the manufacturer of medical devices.
    • EN 15986:2011: Requirements for labeling of medical devices containing phthalates.
    • EN ISO 3826-2:2008: Plastics collapsible containers for human blood and blood components – Part 2: Graphical symbols for use on labels and instruction leaflets.

    Usage of symbols in labels helps to communicate quickly which are efficient, cost saving and internationally understood concepts to convey the required information to the user of a medical device. As labels provide critical risk/benefit information as well as clear instruction for safe use. These symbols used in labels are also used in other range of formats like leaflets, user manuals, brochures.

    • Marketing materials like leaflets and brochures
    • Product packaging
    • Product description
    • User manuals
    • Safety instruction
    • Accompanying software

    Medical device labeling refers to all the information provided by the manufacturer that is attached to, accompanies, or is associated with a medical device. This includes labels on the device or its packaging, instructions for use (IFU), user manuals, safety information, marketing materials like leaflets and brochures, and any other documents that explain the device’s correct and safe use. The purpose of labeling is to ensure that users have all necessary information to safely and effectively use the medical device, in compliance with regulatory requirements such as those set by the EU Medical Device Regulation (EU MDR).

    Yes, labeling is mandatory for all medical devices seeking CE marking under the EU MDR (Medical Device Regulation 2017/745). The labeling must comply with strict requirements including the device name, model number, manufacturer details, CE mark, warnings, instructions for use, date of manufacture, batch number, and a Unique Device Identifier (UDI). Additionally, medical device symbols must be used to ensure clear, multilingual, and internationally understood communication of essential information. Proper labeling is essential for device safety, traceability, and regulatory compliance before placing the device on the EU market.

    “In India, medical device labeling requirements are regulated under the Medical Device Rules, 2017, governed by the Central Drugs Standard Control Organisation (CDSCO). The labels on medical devices must provide essential information to ensure safe and effective use, which includes:

    Name of the device, model/catalogue number, and batch/serial number.
    Name & address of the manufacturer, if applicable, the importer or authorised representative.
    Intended use
    Information (IFU/Labels) on how to safely use the device.
    Any special storage conditions or precautions
    Date of manufacture and expiry, where applicable.
    Warnings, contraindications, and precautions necessary for safe use.
    Information provided in English or Hindi, or in the local language.
    Use of internationally recognised medical device symbols

    All labels must be legible, durable, and securely affixed to the device or its packaging to ensure traceability and user safety.”

    Yes, under the EU MDR, medical device labels must be understandable to users in the countries where the device is marketed. To address language differences, manufacturers often use internationally recognized medical device symbols on labels and packaging. These symbols help convey important information without relying solely on written text, reducing the need for multiple language translations on the label itself. However, any written information, such as instructions for use or warnings, must be provided in the official language(s) of the country where the device is sold or used. This ensures that users can safely and effectively understand the device information.

    Maven offers expertise to ensure your medical device labelling meets all the stringent requirements of the EU MDR 2017/745. We help manufacturers incorporate all mandatory information on labels, including device identification (name, model, serial number), manufacturer details, CE marking, warnings, instructions for use, and the unique device identifier (UDI).

    We ensure proper use of internationally recognised medical device symbols according to standards like EN ISO 15223-1:2021, and where required, assist in language translation. We ensure your labels are in compliance with the General Safety and Performance Requirements (GSPR).

    By partnering with Maven, you can streamline your labelling process and reduce compliance risks.

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