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Europe EU Medical Device

Medtech Connect Episode 5: EU Horizontal Regulations And Digital Tech

  • Interviews

Executive Summary

In this episode of Medtech Connect, Medtech Insight senior regulatory writer Eliza Slawther interviews MedTech Europe’s digital lead Alexander Olbrechts about the interplay between EU medical device laws with proposed horizontal regulations that impact digital devices, such as the AI Act, the Data Act and the European Health Data Space. The importance of international harmonized standards, particularly for cybersecurity, is also discussed.

Further Reading:

The EU NIS 2 Directive Is Here. What Does It Mean For Medtech?

Therapy Chatbots And Medtech Laws: Why AI App Developers Must Tread Carefully

Are Notified Bodies AI-Ready? BSI Teams Up With Expert Firm On Conformity Assessments

Latest Cybersecurity Guidance From IMDRF Highlights Software Bills Of Materials

Q&A: IMDRF Releases Final Legacy Device Cybersecurity Guidance

France Latest Country To Introduce Digital Medtech Reimbursement Fast-Track

Further Listening:

Medtech Connect Episode 4: Intelligent Devices

Our other podcasts are available on the Pharma Intelligence channel on Apple Podcasts, Google Podcasts, SoundCloud and TuneIn - also now on Spotify Podcasts - and via smart speakers if one of these platforms has been set up as your default podcast provider.
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Europe EU Medical Device
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This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

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