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New Guidance Software European Union

Hogan Lovells

New MDCG guidance clarifies rules for medical device software available on online platforms

Hogan Lovells on

The Medical Device Coordination Group (“MDCG”) has issued guidance on the safe making available of medical device software (“MDSW”) apps on online platforms (MDCG 2025-4). MDCG 2025-4 outlines the regulatory roles of online...more

Orrick, Herrington & Sutcliffe LLP

EU Commission Clarifies Definition of AI Systems

The European Commission published guidelines that clarify the definition of AI systems under the AI Act, analyzing each component of the definition of AI system, providing examples and specifying which systems should be...more

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