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