ARTICLE SUMMARY:
In this week’s Pathways Picks: The EU gets active on digital health, with new guidance on app stores and software regulation, and planned resources around the AI Act; the UK’s new postmarket surveillance law takes effect; notified body survey data; EU IVD studies; FDA review performance; and more from the US, Europe, and IMDRF.
Digital Health Picks
EU ramps up guidance development:
App store oversight in the EU. App marketplace providers like Apple and Google must take on EU regulatory responsibilities when selling medical device software (MDSW) from other companies, EU policymakers affirmed in a June 16 guidance document. The Medical Device Coordination Group guidance comes in the context of barriers faced by MDSW makers in ensuring their products are being sold to patients in a compliant manner and that they aren’t competing with software flouting Medical Device or IVD Regulation (MDR/IVDR) rules in third-party app stores. (For more details and response to the guidance see “App Store as Device Distributor? EU Clarifies Regulatory Responsibilities.”)
