Sea Change In Medtech As Industry Leans To US For New Innovation
Reimbursement has become a major obstacle to innovation
Executive Summary
An expansive study shows the US has emerged over Europe as the preferred launch site for new medical technology because the Food and Drug Administration responds more effectively to innovation than do European regulators.
You may also be interested in...
MedTech Forum 2022: Bernasconi Mulls HTA Proposal, Speaks On New Device And Diagnostic Regs
The Medical Device and IVD Regulations are much needed, although solutions must be found quickly to address major problems created on the way. But the HTA Regulation works against the sector, MedTech Europe’s Serge Bernasconi said in a recent interview.
Device Makers Are Bucking Decades-Long Trend Of Launching Products In EU. Here’s Why
In this Medtech Insight Q&A, two UCLA-backed study authors argue that the US FDA “has emerged as the global regulatory agency most successful in promoting access to novel medtech products, especially digitally enabled or software-driven ones.”
Industry Asks Commission To Delay MDR Full Compliance Dates By At Least Two Years
The two largest EU national medtech industry associations, France’s Snitem and Germany’s BVMed, have joined forces to call on the European Commission and other authorities to act now so the MDR and IVDR don’t result in “disaster for patients”.