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Awareness of Symbols

Symbols are an essential part in communication of information on labels of IVD Medical devices - you can find them in virtually all labels.

Well-designed symbols have the advantage of communicating information in a language independent manner, which can be easily understood by all users. For that reason symbols are often used to convey critical safety information on devices.

In order for symbols to be effective, they must be well known. To that effect the EDMA Labelling task force has prepared a number of documents which are useful in understanding symbols and their use.

  • Guidance on user awareness of symbols - Symbols harmonised under the IVD Directive, along with the translation into various languages. (This document is available in the "Members" section of the EDMA web site, restricted by a password).
  • EDMA Symbols for use with IVD reagents/components - This is a list of symbols which have not been included into standard documents, but which are in common use throughout the industry. (Note - to use such symbols, their meaning must be explained in the accompanying instructions)
  • IVD Symbols for reagents and instruments - A list of symbols commonly used in the IVD field, found in various standards, from ISO, CEN, IEC and others. (This document is available in the "Members" section of the EDMA web site, restricted by a password).

The promotion of symbols across the globe simplifies the labelling of IVD devices. It is now widely recognised that symbols are an effective way of communicating critical information to users of devices. As well as in the EU, some symbols are accepted for use by the FDA and EDMA continues to strive  for the wider acceptance of symbols by authorities and users of IVDs.