From EC REP to EU REP: Decoding Critical Medical Device Symbol Changes
Medical Device Global Market Access · Pure Global
July 24, 20253m 25s
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Show Notes
This episode breaks down the essential updates from ISO 15223-1:2021 and its recent 2025 amendment. We explore the new symbols for medical devices, translations, and sterilization, and detail the critical shift from the 'EC REP' to the 'EU REP' symbol, explaining the reasons and the compliance timeline for manufacturers.
Key Questions:
• What is ISO 15223-1:2021 and why is it essential for medical device labeling?
• Which new symbols were introduced in the latest version?
• Why is the 'EC REP' symbol being replaced by 'EU REP'?
• What is the official publication date of the amendment changing the authorized representative symbol?
• Do you need to immediately relabel all your existing products?
• What does 'harmonization' mean and how does it affect your compliance timeline?
• How should manufacturers strategically plan for this transition?
• What are the implications of the new 'MD' and 'Translation' symbols?
Ready to turn these insights into your competitive edge? Pure Global’s regulatory experts guide MedTech companies through every step of 30+ markets worldwide. Explore how we can accelerate your market entry at https://pureglobal.com or email [email protected] for tailored support.