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Publication Digest: An accelerated access pathway for innovative high-risk medical devices under the new European Union Medical Devices and health technology assessment regulations? Analysis and recommendations
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, Tarricone et al. reviewed the new EU regulations for medical devices and health technology assessment, highlighting their potential benefits in increasing clinical evidence quality and reducing fragmentation in the EU market access process. The authors also provided recommendations for the structure of a potential new Accelerated Access Pathway for innovative, high-risk (in particular implantable and class III) medical devices which would fit the pan-European context and safely accelerate patient access.
Access the full-text article here.