Updated requirements and guidance on symbols for use with medical devices

BS EN ISO 15223-1:2021 includes additional symbols to support European regulatory requirements

The Medical Devices Regulation (MDR) (2017/745/EU) and in vitro diagnostic medical devices regulations (IVDR) (2017/746/EU) have requirements that ask for various information to be included on the label of medical devices.   For simplicity and to avoid translation of text, this information can be provided as symbols that have a specific meaning. These symbols can be used on the medical device itself, on its packaging or in the accompanying information. The use of symbols on the label as an alternative to written language is permitted in the MDR. Symbols have to be explained in the Instructions for Use until they are published in a harmonised European standard.

BS EN ISO 15223-1:2021 - Medical devices — Symbols to be used with information to be supplied by the manufacturer - Part 1: General requirements - has been updated to support the requirements in the MDR. This is the fourth edition of the standard that cancels and replaces ISO 15223-1:2016. The main changes compared to the previous edition are:

• addition of 20 new symbols that had undergone validation in multiple languages and geographies with both patients and healthcare providers
• addition of five symbols previously published in other standards
• deletion of the defined term “labelling”
• inclusion of defined terms from other key horizontal standards
• expansion of the examples provided
• move of information about European regulations to informative notes.

The new edition of the standard includes a new European Foreword and two new Annex Zs - designated ZA and ZB – which show the relationship between the clauses of the standard and the requirements of the MDR and IVDR. Publication of the European adoption of the standard make it possible that it could be listed in future in the Official Journal of the European Union as providing a presumption of conformity with the requirements of the European Regulations, with the extent that the requirements are covered being described in the Annex Zs.  

With the publication of this new edition of BS EN ISO 15223-1, MedTech Europe, the European trade association for the medical technology industry including diagnostics, medical devices and digital health, has updated its guidance on use of symbols. This guidance - Use of symbols to indicate compliance with the MDR - has been developed based on information from MedTech Europe members and from the public domain. It should be noted that this document is a guidance document and not a standard or normative document.

Manufacturers will want to be aware of the publication of this important horizontal standard. They should review the detail in the Annex Zs to see how their use of symbols links to their demonstration of conformity with the general safety and performance requirements (GSPRs) of the MDR and IVDR. Manufacturers should also watch out for future publications in the Official Journal of lists of additional standards providing a presumption of conformity with the MDR and IVDR.

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