Over the course of the last few years, a large number of antibody and antigen tests for the detection of the SARS-CoV-2 Virus (COVID-19) have become available in the U.S. under the Food and Drug Administration’s (FDA) Emergency Use Authorization (EUA) Program. Increasingly, manufacturers of EUA-released products have indicated interest in accessing the EU market for such products given the sheer opportunity in this geography.
However, understanding applicable EU requirements for COVID-19 tests can be a daunting endeavor. In particular, the EU regulatory framework for IVD/COVID-19 testing products has shifted greatly with the release of the In Vitro Diagnostic Regulation (IVDR) in May 2022 to the degree that it can be quite overwhelming for IVD manufacturers.
While product availability was previously possible under the In Vitro Diagnostic Directive (IVDD) through conformity assessments conducted by EU Notified Bodies for self-test devices or through self-declaration, there are new and important processes for U.S. manufacturers to consider under IVDR.
Access NAMSA’s latest White Paper, “Expanding your Market: Submitting U.S. EUA COVID-19 Products for EU IVDR Compliance,” as we discuss how to select the best strategy for IVDR compliance, the necessary steps to enter the EU market in an accelerated manner, and how to apply these certification processes to other devices.
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