News on symbols to be used under the MDR and IVDR

MedTech Europe has published an article earlier this year about symbols that have been proposed by the industry association to be included in the new revision of ISO 15223-1. 

MedTech Europe has now announced that some symbols are available on the website of the International Organization for Standardization (ISO). 

The symbols include:

• 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

Please note that the revision of standard 15223-1 is expected to be published later in 2020. It remains to be seen if more symbols will be published on the website, e.g. “medical device” or “unique device identification” as the transition period continues.

To gain access to the website of International Organization for Standardization (ISO) you are welcome to use this link.

For further in depth information on changes accompanying the new regulations, we warmly recommend following articles and pages

The mdi Europa Online Library
Supportive Information Section MDR/IVDR
Major Aspects of the MDR
Major Aspects of the IVDR