While the international standard ISO 15223-1 “Medical Devices – Symbols to be used with medical device labels, labelling and information to be supplied ” is under review, MedTech Europe has submitted their proposal of MDR (EU) 2017/745 – compliant symbols to the relevant Technical Committee, ISO TC 210 WG 3.

EUROPEAN UNION: Proposed guidance for the use of symbols to indicate compliance with MDR (EU) 2017/745

MedTech Europe, for many years an active community contributing to the European Union’s health-related policies and regulations, has taken upon themselves to prepare and publish a guidance containing symbols that can be used in medical device labelling to communicate information on the safe and effective use of such products.

The guidance illustrates graphical symbols meant to convey the following information:

  • medical device;
  • human blood or plasma derivatives;
  • medicinal substance;
  • hazardous substances;
  • biological material of human origin;
  • biological material of animal origin;
  • sterilized using vaporized hydrogen peroxide;
  • translation;
  • repackaging;
  • single patient multiple use.

The list of symbols which – if applied appropriately – will allow manufacturers to ensure the compliance of their products with MDR (EU) 2017/745, is intended at the moment for informational purposes only. Therefore, stakeholders must wait for the final outcome of the ISO revision process of 15223-1 to avoid any discrepancies.