In a sig­nif­i­cant devel­op­ment for med­ical device label­ing, the cur­rent ISO 15223-1 sym­bol indi­cat­ing Euro­pean Autho­rized Representatives—previously denot­ed as EC REP—will soon be updat­ed to EU REP. 

His­tor­i­cal­ly, the EC REP sym­bol rep­re­sent­ed the pres­ence of an autho­rized rep­re­sen­ta­tive act­ing on behalf of non-EU man­u­fac­tur­ers and serv­ing as the crit­i­cal legal link between man­u­fac­tur­ers and reg­u­la­to­ry author­i­ties with­in the EU. The tran­si­tion to the EU REP sym­bol is intend­ed to estab­lish a more stream­lined approach, align­ing the sym­bol with the broad­er and uni­fied iden­ti­ty of the Euro­pean market.

Man­u­fac­tur­ers and stake­hold­ers are encour­aged to pre­pare for this tran­si­tion by updat­ing label­ing mate­ri­als and doc­u­men­ta­tion accord­ing­ly. Please observe our newslet­ter arti­cles on fur­ther infor­ma­tion regard­ing tran­si­tion timelines.

Source: ISO 

Accom­pa­ny­ing this sub­ject we rec­om­mend the fol­low­ing con­tent on our website