September 13, 2022

MDCG 2022-12: “Alternative Solutions” Document. Interim Guidance for IVD Manufacturers  

Author: Criterion Edge Writers

What You Need to Know  

The Medical Device Coordination Group (MDCG) released a new document (MDCG 2022-12) to establish guidelines for in vitro diagnostic medical device (IVD) manufacturers while the EU awaits the European Database on Medical Devices (EUDAMED), a project that was scheduled to be completed years earlier than its now-projected date of Q2 2024.  

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September 6, 2022

European Commission Announces EUDAMED Will be Ready in Q2 2024 – But Can We Believe It? 

Author: Criterion Edge Writers

What You Need to Know 

Already delayed by 4 years, the European Database on Medical Devices (EUDAMED), a European Union (EU) database considered to be the foundation of the EU medical device and in vitro diagnostic regulations (MDR and IVDR), now has an updated timeline for launch, according to the European Commission

Mark Your Calendar  

When the database becomes operational, the following timeline is expected. Of note, it remains uncertain whether EUDAMED modules will have a staggered release.  

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