MedTech Europe: Urges Alignment of EU Digital Laws With Medical Device Rules

05.09.2025

News

MedTech Europe is calling on EU lawmakers to align cross-sector digital legislation – the AI Act, Cybersecurity Act, Data Act and the European Health Data Space (EHDS) – with medical-device requirements to avoid duplicative or conflicting obligations.

In a new position paper, the group backs the Commission’s simplification drive but proposes sector-specific fixes. It also asks to delay the AI Act’s current August 2027 application date by two years, warning the timeline could slow patient access to safe, effective AI-enabled devices.

Source:

MedTech Europe: News – Simplification of EU digital legislation: MedTech Europe proposal to ensure coherent implementation

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