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.
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Medtech needs to closely monitor how the newly adopted EU HTA Regulation is rolled out and actively seek to influence its impact to avoid major obstacles ahead. MedTech Europe’s Oliver Bisazza explains why further shaping of this new text is so critical.
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.
The Commission will present a mixture of likely elements of a legislative proposal for a targeted amendment of the MDR and IVDR for consideration at the 9 December EPSCO Health Council meeting.