Why Industry Anticipates a ‘Cliff-Edge’ Scenario with EU MDR/IVDR

Manufacturers and the European Association of Notified Bodies alike face difficult decisions with the new

EU’s medical device and in vitro diagnostic regulations (MDR/IVDR)

The EU's medical device and in vitro diagnostic regulations (MDR/IVDR) may cause a "cliff-edge scenario," meaning a disruption in the supply of certain medical devices and IVDs, industry groups and the European Commission (EC) recently cautioned.

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