Will you need more space on your labels?

 The new regulations specify additional information to be provided with medical devices

One area that has been changed substantially in the Medical Devices Regulations (MDR) and In Vitro Diagnostic Medical Devices Regulations (IVDR) relates to the information to be provided with medical devices and in vitro diagnostic medical devices (IVDs). Annex I in each Regulation details the general safety and performance requirements. Chapter III of this Annex gives the requirements for information to be supplied with the device. This includes information on the label as well as in the instructions for use (IFU). All labels and IFUs will need to be reviewed and updated. One practical implication of the amount of additional information stipulated to be included in the label is that the labels will likely need to be bigger.

Labels have to have an indication that the product is a medical device or an IVD, as applicable, as well as an indication of the unique device identification (UDI). Some of the other added requirements for the content of labels for medical devices includes, when applicable, an indication:

• that the device contains a medicinal substance, a human blood or plasma derivative, or tissues or cells of human or animal origin, or their derivatives; and,
• of the presence of substances that are carcinogenic, mutagenic, toxic to reproduction or endocrine-disrupting;

For sterile devices and sterile IVDs, the level of packaging (called the sterile barrier system) that maintains the sterility of the device has to be identified and be labelled with an instruction to consult the IFU if the sterile barrier system is damaged or unintentionally opened before use.

One way to reduce the amount of space needed on the labels is to use symbols. This also avoids having to provide the information in multiple languages. The regulations allow that the information supplied by the manufacturer can be provided as internationally recognised symbols. EN ISO 15223, Medical devices – Symbols to be used with medical device labels, labelling and information to be supplied – Part I: General requirements, is the harmonised standard for symbols. It was included in the updated list of harmonised standards in November 2017. This standard superseded EN 980:2008, Symbols for use in the labelling of medical devices, which has been withdrawn and no longer provides a presumption of conformity with the requirements of the medical devices Directives. Symbols used need to conform to the harmonised standards or, if a suitable symbol is not included in EN ISO 15223-1, the symbol used needs be described in the IFU.

The UK has submitted proposals for additional symbols to be included in a revision to EN ISO 15223-1 to meet the needs of the MDR and IVDR. Before they can be included in a revised standard, these proposed symbols need to go through a validation process, to assess their usability so that they are suitable and understandable by the users, This validation process is just starting. Guidance on validation of usability is available, for example, in EN ISO 62366:2008, with its amendment from 2015, titled Medical devices - Application of usability engineering to medical devices.

In developing your plan to transition to the MDR and IVDR, you need to look carefully at the changes needed in the content of the labels and IFUs. You will need to consider how to present all the necessary information, whether you need to increase the size of your labels, and how this will affect your labelling processes and labelling equipment. There are a number of resources available to help with transition planning, including MHRA’s Introductory Guide to new medical device regulations, MedTech Europe’s flowcharts of the regulations and BSI’s white papers and Compliance Navigator.

Author: Eamonn Hoxey, of E V Hoxey Ltd, UK, is a writer, trainer and consultant on a range of life science areas including regulatory compliance, quality management, sterility assurance and standards development.