ARTICLE SUMMARY:
EU reform efforts kick in, CDRH tries to hold the line, AI questions abound, reimbursement models multiply, and global alignment efforts proceed despite strife. The editors of Market Pathways spotlight top medtech market access policy issues on their radar for the year ahead.
US policy in 2025 was chaotic, harsh, and exhausting, a dynamic that stretched to all corners of the federal government and the parties that depend on them. But, by year-end, for the very particular segments of the government that most concern this publication—those with the largest impact on the pathways to market for device, diagnostics, and digital health products—some equilibrium appears to have been reached. This progress is enough to tee up 2026 as a potentially dynamic period at FDA’s device center, which has so far seemed to insulate itself from broader agency drama, and within CMS, which went into overdrive in recent months launching experimental payment models.
In the EU medtech sphere, expectation was a dominant theme of the past year, with continuous rounds of consultations and evaluations on the future of the Medical Device and IVD Regulations. It all culminated in a tangible outcome in December that will define Europe’s device narrative in 2026: a comprehensive legislative proposal that could significantly streamline the regulatory frameworks that have been the source of so much handwringing.
Serious efforts to contend with the challenges of ensuring access to safe and effective devices in the face of tight resources and bracing technological change are leading to important evolutions in medtech policy worldwide, from Mexico City to Kigali to Seoul. And even as the US may have retreated from certain global engagements, other countries are taking tangible steps toward increasing alignment on medtech issues.
Here’s a spotlight on five issues in medtech policy that we’ll be keeping an eye on in 2026, with links to recent Market Pathways articles to offer context. Happy New Year!
