EU IVD Regulation: A New Scrutiny System For Diagnostics
This article was originally published in The Gray Sheet
A European Union-centralized scrutiny system will be put into place for high-risk products under a new EU regulation for in vitro diagnostics that is heading toward adoption in the coming months.
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EU power players are currently negotiating vast changes to how in vitro diagnostics are regulated in Europe. The resulting system will involve a lot more external oversight than today for most IVDs. Here's a rundown of what to expect.
The European Commission has reluctantly allowed virtual audits in the context of new MDR and IVDR. The EU notified body association is helping the collective effort to meet its strict requirements.