Document paper International

Impact of changes under the new EU IVD Regulation (EU) 2017/746 to international registrations

Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) introduces a major update of the regulatory framework in the European Union (EU). This modernisation of the European regulatory system brings about several changes to the information provided with IVD devices and their regulatory documentation.

This document analyses the changes to the regulatory documentation due to the IVDR that might be relevant for product registration outside of EU/EEA. It is addressed to economic operators, and to regulators who are based outside of EU/EEA.

Posted on 26.05.2020

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