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 […]
[FEATURED] EU’s Risk Management Standard Officially Recognized In Context of the IVDRU
Only one new standard has been added to the official list of standards recognized in the context of the EU IVD Regulation in the latest update. The good news is […]
[FEATURED] EU IVD Regulation: Guidance on Significant Changes Now Available
With just a few weeks to go until the IVD Regulation fully applies, much-needed guidance has been published which discusses “significant changes” for legacy IVDs.