healthcare.digital November 23, 2025
Key developments in the European MedTech sector for the week of November 21st 2025, have been dominated by major regulatory shifts regarding AI, significant capital injections and activity surrounding two major industry conferences.
1. Regulatory & Policy: The “AI Act Pause” Proposal
The most significant strategic development this week is the European Commission’s proposal to delay the enforcement of “high-risk” AI rules for medical devices.
The News: As part of a new “Digital Omnibus” package introduced this week, the Commission has proposed a “targeted implementation delay” for the EU AI Act.
Impact: This would effectively pause the enforcement of strict obligations for high-risk AI systems (which includes many AI-driven medical devices) that were set to apply from August 2026.
Why...
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