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MedTech Europe publishes symbols guidance

  • Posted by: inetika
  • Category: GLOBAL NEWS

MedTech Europe (MTE) has issued a guidance document on the use of symbols to indicate compliance with the MDR. The aim is to help manufacturers comply with new MDR requirements in an efficient manner before the relevant international standard is available. The graphical symbols in the guidance have all been validated with users, including patients and healthcare professionals, according to international standards. They have been submitted to ISO (International Standardisation Organisation) and are currently being considered in the revision of ISO 15223-1, ‘Medical Devices – Symbols to be used with medical device labels, labelling and information to be supplied’.

The document covers symbols for the following:

  • Medical device
  • 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
  • Sterilized using vaporized hydrogen peroxide
  • Translation
  • Repackaging
  • Single Patient Multiple use

An annex also recommends symbols to be used with patient implant card.

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