Device Week, 16 July 2021 – An Inside Look At The EU’s Sweeping New Device Regs
Executive Summary
In this week’s podcast, EU regulatory editor Amanda Maxwell walks us through the latest news and documents coming out of the European Union’s efforts to revamp its medical device and diagnostics rules and makes some predictions about what we can expect to see going forward.
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 smart speakers if one of these platforms has been set up as your default podcast provider.
Articles related to this podcast include:
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EU HTA Regulation: ‘Another Layer Of Bureaucracy For Medtech To Overcome’
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New Guidance On Registration Rules For Importers Into The EU
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How Notified Bodies Must Ensure Appropriately Qualified Staff Assess Each IVD
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New MDCG Forms Include Checks On Notified Body Staff Qualification And Training