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    EU IVDR changes regulatory landscape

    This article discusses new requirements for technical documentation, periodic safety reports, notified body changes, postmarket surveillance and vigilance, labeling and product traceability under the European Union’s new In Vitro Diagnostic Regulations (EU IVDR).   Introduction   Many regulatory changes are scheduled to come into effect in May 2022 as part of the new EU IVDR (2017/746.) 1 However, it likely that EU IVDR will come into effect a year later t...