ARTICLE
24 September 2026

(Medical) Crimes And (Data) Misdemeanours - Writing To The European Commission’s AI Act Service Desk Concerning Annex V Of The EU AI Act (Conformity Assessments) - LIVE! (Podcast)

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Marc Dautlich and Alex Denoon explore the complexities of the EU AI Act's Declaration of Conformity requirements, specifically examining what it means for High-Risk AI Systems to comply with GDPR. The podcast addresses the practical challenges providers face when preparing this living document for AI-integrated medical devices and other regulated systems.
United Kingdom Food, Drugs, Healthcare, Life Sciences

In our first episode of (Medical) Crimes and (Data) Misdemeanours, Marc Dautlich and Alex Denoon write to the European Commission’s AI Act Service Desk.

Any High-Risk AI System (and these are the most interesting AI Systems and the focus of the EU AI Act) must be the subject of a Declaration of Conformity prepared by the “provider” (the entity with primary regulatory responsibility for the AI System). This is a living document that confirms that the System (for example, a medical device that integrates some AI) complies with the AI Act (and any other applicable legislation). For this podcast, the relevant provision is Annex V, point 5. The DoC must include a statement that the AI System “complies with GDPR”. Sounds easy, but what does it mean in practice?

Note: All information was correct at the time of recording.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

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