Getting ready for the In Vitro Diagnostic Regulation
The IVD Regulation replaces the European Directive IVDD (Directive 98/79/EC) for IVD devices, with the aim of ensuring a high level of protection of public health, patients, and users.
More rigorous analytical and clinical performance studies.
What’s new for users? New packaging labeling & IFU update; Eudamed database: more transparency and traceability; Closed validated analytical solutions focus only on results quality.
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