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. […]
The Summary of Safety and Clinical Performance (SSCP) is a Required Part of Medical Device Regulation (MDR) 2017/745: Is Your Organization Ready?
Author: Suzanne Broussard The Summary of Safety and Clinical Performance (SSCP) plays an important part of the very strong post-market follow-up required in MDR 2017/745 for implantable and class III medical devices. The SSCP is intended to provide healthcare workers and […]
