EU IVDR: Bisazza Explains Why Regulators Must Act Now To Defuse ‘Ticking Timebomb’
Industry’s message may continue in a similar vein, but the urgency over the implementation of the EU IVDR has grown to a point where it is desperate for some solution to what it sees as an impending disaster for IVDs in the EU.
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The medtech industry’s call for a one-year delay to the Medical Device Regulation and for EU-wide exceptions from usual medical device rules was granted recently. But not for IVDs, where the situation is described as “grim.”
Artificial intelligence is incorporated into medical devices and IVDs with increasing frequency. But it is only now that the EU is working on how that process will be regulated.
For the first time in nine years, the European Commission looking at the extent to which IFU for medical devices may be made available electronically.