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How to Best Implement the EU IVDR – Dos and Don’ts

Topic : Regulation Type : Briefing

This white paper is built around a table that seeks to provide a checklist for IVDR preparation, based on the requirements of EU Regulation 2017/746. The checklist provides a comprehensive list of actions envisaged for the manufacturer for new devices and for legacy IVDs during and after the new transitional periods of the IVDR. In order to provide context to the checklist, each table is preceded by a short discussion of changes for that respective chapter in the IVDR.