Insights for FDA Regulated and HIPAA Compliant Organizations
Marketing Diagnostic Testing Services in the EU
Many of our US-based diagnostic testing clients are having us 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 will soon change under the new In Vitro Diagnostic Regulation (IVDR 2017/746).
It is estimated that 80% of the current self-certified IVDs will be up classified 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 (26 May 2022) 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