Market Access Strategy for Medical Devices in Europe
Strategic recommendations on the topic of market access pathways for medical devices and IVD tests
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Publication Digest: Innovative Clinical Trial Approach for Evaluating Digital Medical Devices Under European Fast-Track Regulatory Frameworks
MTRC shares the most relevant and impactful publications in the field of market access and HEOR for medical technologies in Europe through its Publications Digest.
In a recent publication, Ursino et al. proposed a statistical framework for evaluating digital medical devices under European fast-track HTA pathways, where temporary access and reimbursement may be granted despite incomplete clinical evidence.
The authors developed a three-step approach combining interim clinical trial analysis, final trial analysis, and meta-analysis of trial data with real-world data collected after temporary authorization. Simulation results showed that the framework may help optimize the timing of provisional access decisions and strengthen evidence generation for final HTA evaluation.
Access the full-text article here.