Many of our US-based diagnostic testing clients are having Allied help them move into the EU marketplace
In order to commercialize in vitro diagnostic (IVD) in the European Union, a CE Mark certificate is needed. This certification verifies that a device meets all regulatory requirements for IVDs, which recently changed under the new In Vitro Diagnostic Regulation (IVDR 2017/746).
It is estimated that 80% of the current self-certified IVDs must be reclassified to require Notified Body involvement under the IVDR.
IVDs that are up-classified from self-certified to require Notified Body involvement will need a Notified Body-issued IVDR certificate on the date of application to continue to market the product.
Learn how TAGmedica and our partner Titan Solutions can help by checking out our article CE Mark Process for In Vitro Diagnostic (IVD) Devices