EU REP Symbol Transition: Compliance Guide for Medical Device Labeling by 2031

This episode details the formal transition from the 'EC REP' to the 'EU REP' symbol for European Authorized Representatives on medical device and IVD labeling. We discuss the implications of the amended harmonized standard EN ISO 15223-1:2021/A1:2025, published on June 17, 2026. The host explains the 60-month transition period, which ends on June 17, 2031, and provides practical, actionable steps for manufacturers to update their technical documentation, QMS, labeling, and packaging to ensure continued compliance in the European Union. Key Questions: - What is the significance of the EU REP symbol change? - When is the official deadline to stop using the EC REP symbol? - Does this change affect both medical devices and IVDs? - What specific standard was updated to formalize this transition? - How long is the transition period for implementing the new EU REP symbol? - What are the first steps a manufacturer should take to manage this change? - How does this labeling update impact technical documentation and the QMS? - Should manufacturers coordinate this change with their Notified Body? - Can both the EC REP and EU REP symbols be used simultaneously during the transition? - What is a practical strategy for updating packaging and labeling across a large product portfolio? Sources: - https://www.medqair.com/medical-device-regulatory-news/ec-rep-to-eu-rep-what-the-ojeu-publication-means-in-practice - https://www.decomplix.com/regulatory-news/ - https://www.pure-global.com/regulatory-updates How Pure Global can help: Pure Global provides end-to-end regulatory consulting for MedTech and IVD companies, streamlining global market access. We act as your local representative in over 30 markets, develop efficient regulatory strategies, and use advanced AI to compile and manage technical dossiers for submission. Our team of local experts helps you navigate complex requirements like labeling changes to ensure your products remain compliant and reach markets faster. For support with your EU regulatory strategy and technical file updates, contact us at [email protected] or visit https://pureglobal.com. Explore our free AI tools and regulatory database at https://pureglobal.ai.