Medtech firms face EU digital regulation challenges, warns Medtech Magazine
Photo by Milad Fakurian on Unsplash
Pernilla Norman writes in Medtech Magazine that the EU's "digital decade" legislation, including the "omnibus package" intended to simplify administrative processes, could paradoxically increase complexity for medtech companies through revisions to the GDPR and the AI Act. Multiple acts like the Digital Markets Act, Digital Services Act, NIS2 Directive, Data Act, and Cyber Resilience Act may create an increasingly complex regulatory environment, which could undermine the EU's simplification goal.
Key takeaways
- In a recent opinion piece published in Medtech Magazine, Pernilla Norman cautions that the European Union's forthcoming "digital decade" legislation may present unforeseen challenges for medtech companies
- Norman argues that the EU's proposed "omnibus package," designed to streamline administrative processes, paradoxically risks augmenting complexity through revisions to the General Data Protection Regulation (GDPR) and the AI Act
- She emphasizes that the Digital Markets Act, Digital Services Act, NIS2 Directive, Data Act, and Cyber Resilience Act collectively contribute to an increasingly intricate regulatory environment for the medtech industry, potentially jeopardizing the EU's stated objective of simplification
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