The European Commission has published in the Official Journal of the European Union (OJEU) the…
MDCG Guidance note: UDI within organization’s QMS
The MDCG has released a new Guidance note on how to implement the MDR /…
MDCG Explanatory note on IVDR codes
The MDCG has issued its 2021-14 Guidance related to assignment of codes to in vitro…
MDCG Q&A on EUDAMED Actor registration for importers (update)
The MDCG has released a revised version of Questions & Answers document clarifying actor registration…
Expert panels: First opinion on Class III implantable device released
What is the role of Expert panels? According to articles 106 and 48(6) of the…
MDCG Q&A on EUDAMED Actor registration for legacy & custom-made device manufacturers, SPPP
The MDCG has released a Questions & Answers document clarifying actor registration obligations in accordance…
IVDR: 5th Notified Body on NANDO!
The NANDO database is richer for a new Notified Body under the IVDR! DEKRA Certification…
IVDR Joint Implementation Plan: Priority actions
Following the challenges encountered by the whole sector in the implementation of the IVDR, the Medical Device Coordination…
MDCG on EMDN & IMDRF (UDI)
The MDCG has endorsed two new documents today! The first FAQ MDCG 2021-12 lays down…
Switzerland & MDR DoA: Update
In the light of the approaching MDR date of application (26 May 2021) without the…