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Ea Wright
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The Genotype Network
LE4D Global Regulatory Service
Ea Wright
Home
About
LifeLines
Contact
The Genotype Network
LE4D Global Regulatory Service
Home
About
LifeLines
Contact
The Genotype Network
LE4D Global Regulatory Service
Consolidated version of the AI Act published
Medical Devices, AI Act, Software as a Medical Device Elisabethann Wright 12/08/2026 Medical Devices, AI Act, Software as a Medical Device Elisabethann Wright 12/08/2026

Consolidated version of the AI Act published

A consolidated version of the AI Act that includes revisions introduced in July 2026 has been published. Contrary to expectations in some corners, software as a medical device remain classified as high risk

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Two European Parliament Committees vote to delay entry into application of AI rules for Medical Devices
Medical Devices, AI Act Elisabethann Wright 27/03/2026 Medical Devices, AI Act Elisabethann Wright 27/03/2026

Two European Parliament Committees vote to delay entry into application of AI rules for Medical Devices

The European Parliament’s Internal Market Committee and Civil Liberties Committee have voted by a substantial majority to postpone certain rules on artificial intelligence which will have an impact on medical device manufacturers.

The postponement is intended to prevent

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