))
From EC REP to EU REP: Decoding Critical Medical Device Symbol Changes
Manage episode 496281593 series 3667504
Content provided by Pure Global. All podcast content including episodes, graphics, and podcast descriptions are uploaded and provided directly by Pure Global or their podcast platform partner. If you believe someone is using your copyrighted work without your permission, you can follow the process outlined here https://podcastplayer.com/legal.
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.
…
continue reading
82 episodes
Share
