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 […]
EUDAMED3 Update: Two More Eudamed Modules Will Be Available Later This Year & Guidance on Alternatives Until the Remaining Three Modules are Released and the Database is Fully Functional
Author: Suzanne Broussard, PhD | May 3, 2021 By the end of the year, the first three modules will be accessible on the European medical device database, Eudamed3: Actor Registration, Unique Device Identifiers (UDI)/Device Registration, and Notified Bodies Certificates. […]