September 29, 2020

[FEATURED] EU IVDR: Risk Of Noncompliance Is A Real Threat Under Current Deadline Pressures

Cries for the EU to pay more attention to IVDs are growing louder by the day. It is feared the EU IVD sector is heading for a crisis and safe products will have to be pulled from the market.

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April 11, 2019

[FEATURED] IVDR Notified Body Numbers – Has Enough Progress Been Made?

Will there be enough resources for IVD manufacturers to be audited in time against the EU’s IVD Regulation? A survey from TEAM-NB reveals a drop in notified body numbers just at a time when more resources are needed.

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