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  • Feature ArticlesFeature Articles

    Getting ready for the EU IVDR transition

    This article discusses a manufacturer’s challenges and solutions to preparing currently marketed in vitro diagnostic (IVD) devices for new requirements under the In Vitro Diagnostic Device Regulation (EU IVDR) 2017/746.   Introduction It is daunting, in the best times, to work together to develop and manufacture IVD tests and instrumentation and coordinate their readiness for regulatory review. To get functional area heads in a global company to review and summarize ...