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] Timelines And Deadlines For Stakeholders To Submit Information To EU’s Eudamed Database
IT system deadlines are renowned for being delayed. With speculation that the full implementation of the Eudamed medical device database will be postponed again, what will this mean for stakeholders? […]