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Navigating medicinal products development and assessment involving companion diagnostics: A guide to addressing key questions under Regulation 2017/746 (IVDR) 

This Q&As document outlines the European Medicines Agency’s (EMA) perspective on critical issues related to the development and assessment of medicinal products, especially those involving companion diagnostics (CDx), following the implementation of Regulation 2017/746 (IVDR). It aims to o...
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Revision of MedDO and IVDO

New requirements for product groups without an intended medical purpose and alignment with Regulation (EU) 2023/607 on medical devices and in vitro diagnostic medical devices. The Federal Council of Switzerland has decided to amend the Medical Devices Ordinance (MedDO) in alignment with EU requireme...
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