The EU NIS 2 Directive Is Here. What Does It Mean For Medtech?
Medtech Connect Episode 5: EU Horizontal Regulations And Digital Tech
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.
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