Market Access Strategy for Medical Devices in Europe
Strategic recommendations on the topic of market access pathways for medical devices and IVD tests
Recent news and posts
MTRC has released a White Paper "Evidence requirements for AI-based technologies in Europe"
Across Europe, interest in deploying AI-based decision-support tools is growing rapidly, particularly in areas such as radiology, stroke imaging, endoscopy, and cancer screening.
However, health technology assessment (HTA) agencies consistently emphasize that adoption should be guided by robust, context-specific evidence demonstrating clinical benefit, safety, and cost-effectiveness.
In this White paper, we reviewed evidence requirements for AI-based technologies as identified in five recent European HTA assessments, including urgent-care fracture detection (NICE, UK), hyperacute stroke imaging (NICE, UK), colonoscopic polyp detection (Danish Health Technology Council), and breast cancer screening programs (OSTEBA in Spain and SBU in Sweden).
These diverse cases highlight common expectations and important differences in how national HTA bodies evaluate AI solutions.
Read more and request a White Paper to get practical insights into the evolving evidence expectations for stakeholders seeking to enable safe, effective, and sustainable integration of AI technologies into clinical practice.