Device Week, 13 October 2021 – Spotlight On The Latest Medtech Industry News From The EU
Executive Summary
In this week’s podcast, EU regulatory editor Amanda Maxwell brings listeners up to speed on the latest news from the European Union. Topics include discussion of ISO 13485, ongoing industry concerns with MDR implementation, and the Eudamed database expansion.
Listen to the podcast via the player below:
The archive of Device Week and the rest of Informa Pharma Intelligence’s podcasts are available on the Informa Pharma Intelligence channel on Apple Podcasts, Google Podcasts, SoundCloud, TuneIn, Spotify Podcasts and via smart speakers if one of these platforms has been set up as your default podcast provider.
Medtech Insight articles addressing topics discussed in this episode:
- European Regulatory Roundup, September 2021: EN ISO 13485 Updated And More Key Implementation Developments
- EU Classification ‘Bible’ Published To Support Risk Class Decision-Making
- Two New Modules Added To Eudamed For Use On Voluntary Basis
- EN ISO 13485 and EN ISO 14971: Next Wave Of EU Standards Now Due “By December”