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New symbols for MDR now available on ISO website

  • Posted by: inetika
  • Category: GLOBAL NEWS

The Medical Devices Regulation (MDR, 2017/745) requires a significant number of new details to be added to the labels of medical devices. To ease the burden on manufacturers, symbols may be used in order to avoid translation issues.

In May 2019, MedTech Europe published guidance on symbols recommended for use on medical device labels for MDR compliance prior to the forthcoming revision of ISO standard 15223-1. As a result, among others, the following symbols are now included on the ISO website:

  • Contains human blood or plasma derivatives
  • Contains a medicinal substance
  • Contains hazardous substances
  • Contains biological material of human origin
  • Contains biological material of animal origin
  • Translation
  • Repackaging
  • Single Patient Multiple use
  • Importer
  • Distributor

These symbols do not cover all of the new MDR labeling requirements – others are being considered during the revision process for ISO 15223-1, the next edition of which will feature these new symbols.