Are you an IVD manufacturer with your product on the market in the U.S. looking to scale your product into the European market? Are you in the process of transitioning your product to the European Union In Vitro Diagnostic Regulation (EU IVDR)? Have you considered the implications of the risk-based framework on the path to market for your IVD? There are many challenges faced by IVD manufacturers as they navigate the evolving global regulatory landscapes. Read more to examine the impact of the risk-based classification on manufacturers and gain insight to navigate the complexity of IVD regulations.
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