ARTICLE SUMMARY:
In this week’s Pathways Picks: MDR and IVD reform proposals expected December 16; EU-wide health technology assessments planned; paired programs from CMS and FDA to accelerate digital health; AI billing code chatter; TAP feedback; IVD handbook in India; and more policy updates from Asia, Europe, and the US.
Awaiting Action in the EU
Reform proposals for MDR/IVDR next week, and HTA and AI Act updates:
MDR/IVDR proposals imminent. The European Commission is expected to publish long-awaited proposals for “targeted revisions” to the Medical Device and IVD Regulations (MDR/IVDR) on December 16. The package may address the fundamental governance structure for the regulations, the prospect for creating specialized pathways for certain devices, strategies for removing burdens and increasing consistency between notified body assessments, and other issues such as structured dialogue between manufacturers and notified bodies. The legislative proposals need to be put before the European Parliament and Council to be enacted. The Commission is also pursuing non-legislative revisions to improve access and regulatory consistency.
