EU AI Act
Built for the rules that still apply.
TDVeriX Med is professional decision-support for Notified Body technical-documentation assessment. For this intended purpose under Regulation (EU) 2024/1689, it is classified as not a high-risk AI system, and designed for the transparency and human-authority obligations that still apply.
Where TDVeriX Med sits
Assists EU Notified Bodies with medical-device technical-documentation assessment: finding their way through TD submission dossiers, navigating evidence, and drafting source-linked analysis for auditor review.
- Not a medical device, and not software as a medical device.
- Does not make autonomous certification, CE-marking, or conformity-assessment decisions.
- Documented as not high-risk for this intended purpose under the Act's high-risk map.
- Still an AI system in scope. Transparency, literacy, and prohibited-practice rules still apply.
What conformity means here
Alignment is shown in how the product behaves, not in a compliance badge. TDVeriX Med is built so auditors stay in charge, evidence stays citeable, and AI stays visible.
- AI assistance is disclosed where auditors interact with it.
- Generative output is draft material with paths to source evidence.
- Authenticated humans own final dossier disposition before conclusions enter the formal record.
- AI literacy and change control for model and prompt updates are part of our operating model.
Want the argument, not only the posture?
Our Perspectives essay on the AI Act, MDR assessment, and why transparency is a design requirement, not a footer badge.