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EU medical device regulation stifles SMEs

The EU MDR regulation requires 2,000 pages of documentation for a simple medical device.

Published 4j1 sourceNotable
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The fact

Small businesses struggle with these administrative and technical costs.

Experts advocate for a risk-proportionate approach.

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Why it matters

Cette réglementation pourrait réduire l'innovation et limiter l'accès à des dispositifs médicaux essentiels, notamment pour les patients en Europe.

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Auto-synthesis from 1 media source · identified on August 18, 2026
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