Impact of MDCG 2021-21 on SARS-CoV-2 IVDs

by AKRN Scientific Consulting

This article will provide you information on MDCG 2021-21 guidance document and let you know how you can place and keep your SARS-CoV-2 IVD products on the EU market.

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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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