New EU IVD regulation will impose 'huge system shift'

摘要

As the leading company in the global IVD market, Roche Diagnostics has followed the progress of the proposed overhaul of the regulatory framework for IVDs in the EU every step of the way as it makes it way through the complex EU legislative system. In the Q&A below, Roche's government affairs manager Rebecca Jungwirth, gives Roche's views on the matter