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 Non-IVD Diagnostic Technologies under NICE’s HealthTech Programme”
Health technology assessment (HTA) plays a key role in market access for medical technologies in England. The National Institute for Health and Care Excellence (NICE) is the main HTA body and is responsible for evaluating diagnostics, devices, and digital tools.
In July 2025, NICE consolidated three of its former programs - Diagnostics Assessment, Interventional Procedures, and Medical Technologies - into a unified NICE HealthTech Program. This new structure reflects a lifecycle-based approach, but the evidence principles from the previous Diagnostics Assessment Programme (DAP) still inform current evaluations.
This white paper reviews five assessments of non-IVD diagnostic technologies conducted under the former Diagnostics Assessment Programme (DAP) framework. Despite procedural changes, the case studies offer enduring insights into NICE’s evidence expectations and key factors influencing recommendation outcomes.
These findings can support companies in developing effective evidence generation strategies and navigating market access for similar diagnostic technologies in the UK.
Read more and request a White Paper here.