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