AI Act × MDR Trilemma Check

The EU AI Act (EU 2024/1689) and MDR/IVDR interlock for AI software. This check shows whether dual conformity applies, based on Art. 6 of the AI Act.

Question 1 of 3

Is your product a medical device or IVD under MDR (EU 2017/745) or IVDR (EU 2017/746)?

Orientation only, not a substitute for a regulatory assessment.

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MHRA and Manchester NHS launch a health innovation sandbox: an early signal for AI-enabled devices

The Manchester Sandbox moves the evidence conversation for AI-enabled medical devices into real NHS settings. It is a regulator-enabled evidence environment, not a new authorization pathway, and key operational details have not been published.

ArticleAug 25, 2026

FDA and generative AI: no new policy, but a regulatory framework is taking shape

On 18 August 2026 the FDA published its discussion paper on the regulation of generative AI-enabled medical devices. It is not draft guidance, not final guidance and not a new policy statement. It should not, however, be dismissed as merely exploratory.

ArticleJun 18, 2026

Computer System Validation: Two New Standards, One 12-Week Window

The revised Annex 11 is in final consultation. Annex 22 sits alongside it in draft: the EU's first dedicated guidance on AI in GMP manufacturing. Read them side by side and the message is the same. The bar for trusting a computerised system is moving up.

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