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 […]
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 […]