On 17 August 2026, the European Medicines Agency (EMA) opened a public consultation on the draft European medicines regulatory network (EMRN) Data Standards Framework. The framework supports the mandate of the Network Data Steering Group (NDSG), a joint governance body of the EMA and the Heads of Medicines Agencies (HMA), and proposes a governance framework for the adoption, development, updating and implementation of data standards across the European medicines regulatory ne

On 18 August 2026, the U.S. Food and Drug Administration (FDA) issued a discussion paper seeking early stakeholder input on potential approaches to the regulation of generative artificial intelligence (GenAI)-enabled medical devices. Importantly, this is not a regulatory consultation on draft guidance or proposed policy. Rather, FDA is using the discussion paper to seek early stakeholder feedback and inform CDRH's ongoing consideration of regulatory approaches.

On 16 December 2025, the European Commission adopted and published a proposal for a Regulation amending Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) with the aim of simplifying the regulatory framework and reducing unnecessary burden.

On 14 July 2026, the U.S. Food and Drug Administration (FDA) requested input to support its 2026 report on certain healthcare-related software functions that are excluded from the statutory definition of a medical device. FDA is seeking information on their impact on patient safety, associated health benefits and risks, and best practices relating to safety, education, and competency.