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AI Act: Guidelines for Medical Device Manufacturers according to MDR (2026)

AI Act: Guidelines for Medical Device Manufacturers according to MDR (2026)

by Alexander Fenkiw | Jan 27, 2026 | AI, medical-software-whitepaper

With the EU AI Act, the EU is now also regulating the use of artificial intelligence (AI). This also affects manufacturers of software medical devices who integrate AI into their MDR medical devices (“Medical Device Artificial Intelligence” or MDAI). The AI Act is...

Insider-Empfehlungen für DiGA-Hersteller in 2026
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Insider-Empfehlungen für Software-Medizinprodukt-Hersteller in 2026
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+49 (0) 89 54998380
kontakt@quickbirdmedical.com

Are you planning to develop medical software or a digital health application?

Speak with our managing director, Malte Bucksch

+49 (0) 89 54998380
contact@quickbirdmedical.com
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