EU In-Vitro Diagnostics

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.

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Interpret and implement standards and regulation with ease

BSI Compliance Navigator is the only platform designed by regulatory experts to help manage your medical device compliance, all in one place. Access thousands of standards and regulations, from MDR and IVDR to MDSAP requirements, we have you covered. 

What's more, Compliance Navigator will alert you of any upcoming changes to relevant standards and regulations, meaning you can prepare, far in advance. Use our Tracked Changes to see what's changed quickly and efficiently, followed by our Expert Commentary to help interpret and implement with ease. Save time, reduce risk and unlock market access with Compliance Navigator.

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