ARTICLE SUMMARY:
The EU's proposed product liability directive portends potentially significant risk to medtechs that market their products in Europe; FDA's game plan for its one-year chairmanship of the International Medical Device Regulators Forum management committee; Siemens pushes lawmakers hard for more predictable reimbursement of AI-based tools; MDMA's Mark Leahey on the year ahead in medtech; and practical go-to-market tips from US, EU and UK regulatory experts.
