An EU Company Perspective From Omega Diagnostics
Omega Diagnostics' Michael Gordon explains why the EU IVD market is likely become much more challenging soon – and not always for the right reasons.
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The proposed EU In Vitro Diagnostics Regulation will introduce a tougher system of regulation that will bring increased intervention of notified bodies into the compliance pathway. Companies selling IVDs into the EU market are beginning to factor in rising costs and other challenges before it takes effect.
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