ARTICLE SUMMARY:
In this week’s Pathways Picks: The EU issues a hotly anticipated guide on the “interplay” between the new AI Act and established device and diagnostic regulations; the UK stays active on AI; a Medical Device Single Audit Program forum; CDRH Director Michelle Tarver appears on the FDA commissioner’s podcast; electronic instructions in Europe; global picks from South Korea, India, Brazil, and Saudi Arabia; and more.
AI Picks
EU addresses AI Act-MDR interplay, and UK activity:
Aligning EU rules. AI-enabled medical device developers will be able to compile one set of technical files to cover requirements of the nascent EU AI Act and the Medical Device and IVD Regulations. They will also be able to submit to only one conformity assessment process for the combined rules. This anticipated streamlining was confirmed in a new guidance published jointly last week by the EU Medical Device Coordination Group and the Union’s newly established AI Board. But there are still important new mandates that device companies will need to address under the AI Act, which will activate new conformity assessment requirements for most devices in 2027. Data governance and labeling requirements are two specific areas where the AI Act will elevate expectations for device makers, the guidance, titled “Interplay between the Medical Devices Regulation (MDR) & In vitro Diagnostic Medical Devices Regulation (IVDR) and the Artificial Intelligence Act (AIA),” makes clear.
