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Medical Device Labelling

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Medical Device Labelling

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 on medical device symbols and labelling, please click the following link https://mavenprofserv.com/unique-device-identifier-for-medical-devices/

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
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’;
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,
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
23.2 l) if the device is supplied sterile, an indication of its sterile state and the sterilization method;
MDR Article 16 Point 3
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.

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

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

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