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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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MDCG Guidance on the Safe Making Available of Medical Device Software (MDSW) Apps on Online Platforms
Medical Devices, MDCG Guidelines, Software as a Medical Device Elisabethann Wright 18/07/2025 Medical Devices, MDCG Guidelines, Software as a Medical Device Elisabethann Wright 18/07/2025

MDCG Guidance on the Safe Making Available of Medical Device Software (MDSW) Apps on Online Platforms

The Medical Device Coordination Group (MDCG) has published MDCG 2025-4, which provides guidance on the safe making available of medical device software (MDSW) apps on online platforms.

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