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

Medical Device Global Market Access · Jul 16, 2026 · 5m

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…