Mar 4, 2016

A recent white paper published by Emergo discusses European rules regarding use of labeling and symbols for medical devices, and how electronic labeling as well as harmonization standards are impacting compliance under EU medical device and IVD directives.

The EU recognizes more than 20 official languages, note white paper authors Jennifer Tribbett and Megan Gottlieb, making the task of setting up uniform labeling requirements for a single, huge and heterogeneous medical device market challenging. Symbols and e-labeling have both emerged as useful tools to address European labeling rules.

Key points

The following topics related to European labeling and symbols are covered in-depth in the white paper:

  • Two main standards—EN 980:2008 (“Symbols for Use in the Labeling of Medical Devices”) and EN 1041:2008 (“Information Supplied by the Manufacturer of Medical Devices”)—currently harmonized with EU regulations
  • Symbol categories such as manufacturing, storage, safe use and sterility
  • How European medical device and IVD directives address e-labeling
  • Best practices for labeling, use of symbols and e-labeling

To learn more about European labeling and symbol requirements, download the full white paper. 


  • Stewart Eisenhart