ARTICLE SUMMARY:
In this week’s Pathways Picks: EU lawmakers seek to clarify MDR/IVDR, not AI Act, as controlling authority over AI-enabled devices; MDR certifications grow; FDA issues guide on patient preference information; active South Korea agency approves first generative AI device and expands real-world evidence use; and more updates from Europe, the US, and South Africa.
Top Pick: Less AI Act to Worry About?
Parliament recognizes MDR/IVDR control for AI devices:
It is becoming less likely that AI-enabled devices will be subject to duplicate requirements from the EU’s Artificial Intelligence Act with recent actions from European policymakers.
Last week, the European Parliament approved draft amendments to the European Commission’s November-proposed AI Act reforms (AI Omnibus). Notably, the Parliament’s version of the reform bill would change the status of the MDR/IVDR within the AI Act (from “Section A” to “Section B” of Annex I) so that those sector-specific laws would dictate primary requirements for AI-enabled devices and IVDs, and the separate AI law would only serve as a supporting framework if deemed necessary. It is anticipated that notified bodies would still need to prove AI-specific competencies of the type outlined in the AI Act, but there would be no distinct conformity assessment authorities from what is included in the MDR and IVDR. The Commission signaled its support for this same adjustment in December as part its MDR and IVDR reform proposal that just entered the legislative debate process.
Industry had feared that conformity assessment mandates in the AI Act for high-risk AI (originally scheduled to start in 2027 but potentially delayed to 2028 under the reforms) could unnecessarily complicate the MDR/IVDR assessment process. “Now we only need the Council to be equally smart about this and a major problem has been solved,” Erik Vollebregt, a partner at Axon Lawyers and device legal expert, noted on LinkedIn.
The Parliament, Council, and Commission are expected to enter in final trilogue negotiations on the AI Omnibus sometime in April.
