Medtech Connect Episode 5: EU Horizontal Regulations And Digital Tech
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
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