AI Act Conformity Assessment (Medical Devices)
For AI-enabled medical devices, AI Act requirements are assessed through the MDR/IVDR notified-body procedure, not a separate CE route.
Definition
Article 43(3) provides that where an AI system is a safety component of, or is itself, a product covered by Annex I legislation such as the MDR or IVDR, the AI Act requirements are checked as part of the conformity assessment procedure under that legislation. The notified body performing the MDR/IVDR assessment therefore extends its scope to cover the relevant AI Act articles.What this means in practice
Practically, manufacturers must ensure their notified body is designated for the AI Act scope relevant to the device. Technical documentation under MDR Annex II or IVDR Annex II must be extended to include the AI Act Annex IV elements (data governance, training methodology, evaluation, cybersecurity, human oversight).- •Selecting a notified body designated only under MDR without confirming AI Act scope designation.
- •Duplicating documentation instead of integrating AI Act evidence into the existing technical file.
Related terms
Grouped by themeEditor's picks
· Hand-selected related conceptsThe information set a provider must maintain to demonstrate a high-risk AI system's compliance with Articles 8 to 15.
AI systems captured by Article 6 of the EU AI Act because they are safety components of regulated products or listed in Annex III.
EU-designated organization that assesses conformity of medical devices under MDR and IVDR.
More in Regulatory
· Same categoryFDA submission demonstrating a device is substantially equivalent to a legally marketed predicate.
Two alternative disclosure mechanisms in a 510(k) submission, a Summary is public on FDA's website; a Statement promises to share Safety & Effectiveness info on request.
Formal mechanism to ask FDA whether a product is a device and, if so, its likely classification.
510(k) variant that relies on FDA guidance, special controls, or recognized consensus standards.
Where this term appears across MedTech Terms.
Primary references
3 sources- 1
Regulation (EU) 2024/1689, Article 43VerifiedEUR-Lexeur-lex.europa.eu
- 2
RAPS Regulatory FocusVerifiedRAPSraps.org
- 3
FDA - Medical DevicesVerifiedFDAfda.gov
Inline markers like [1] jump to the matching reference above.