Compare HMA-EMA AI workplan and EU AI Act

How to read this page

How they are linked says why these two documents are connected. Links explained
Side by side places facts from each record together, so you can see status, weight and dates at a glance.
It does not compare content. It does not say which is stricter. Read the official texts for that.

Details: Guide Definitions: every term and label explained

How they are linked

HMA-EMA AI workplan is related to EU AI Act · Source Unverified link

Side by side

	HMA-EMA AI workplan	EU AI Act
Authority	EMA	European Union
Legal weight	Guidance & Q&A	Law & regulation
Status	Final	Effective · phased
Last verified	Not yet	Not yet
Summary	Joint HMA and EMA workplan for artificial intelligence in medicines regulation, 2023 to 2028. It is a plan, not a requirement.	Horizontal EU law on AI systems, applying in phases. AI literacy duties already apply; transparency duties (Art. 50) apply from 2 August 2026. The 2026 digital omnibus moved high-risk obligations to December 2027 (Annex III) and August 2028 (Annex I, e.g. devices).
Lifecycle	18 Dec 2023 Published	1 Aug 2024 Entered into force (obligations phased) 27 Jul 2026 Digital Omnibus on AI, Regulation (EU) 2026/1744, in force (published in the Official Journal 24 Jul 2026); defers high-risk obligations 2 Aug 2026 Article 50 transparency duties apply (Art. 50(2) marking for systems already on the market: 2 Dec 2026, per the Omnibus) Target 2 Dec 2027 Annex III high-risk obligations apply Target 2 Aug 2028 Annex I (product-embedded, e.g. devices) high-risk obligations apply
Source	Official text Source: EMA.	Official text Source: European Union. Licensed under CC BY 4.0.

These facts are placed side by side from each record. This page does not say which is stricter or whether requirements differ. Read the official texts.