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NEW YORK – By 2022, makers of in vitro diagnostics are supposed to have their tests approved under new European guidelines that have remade the regulatory landscape for IVDs and medical devices.

However, the lack of a ready infrastructure has some manufacturers spooked about a regulatory bottleneck as the date for compliance draws closer. In particular, Eudamed, a new database at the heart of the new regulations, has not yet been launched to handle submissions.

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