Preparation is key: brief checklist how to bring IVD MD into compliance with EU IVDR

by AKRN Scientific Consulting

The transition time for In vitro diagnostic medical devices (IVDs) to comply with the EU IVD Regulation 2016/746 (IVDR) is arriving at its end: IVDR will be fully implemented from 26 May 2022. New IVD...

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List of Notified Bodies under IVDR (EU) 2017/746 on In-Vitro Diagnostic Medical Devices

by AKRN Scientific Consulting

A Notified Body is an organization that assesses the conformity of certain products before being placed on the EU market. The conformity assessment is a process by which you demonstrate that the produ...

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