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…
UDI Helpdesk ready for use!
The European Commission has launched the UDI (Unique Device Identification) Helpdesk to provide assistance in…
Standardisation request for the EU MDR & IVDR: update
The European Commission has informed that the Standardisation request from 14.4.2021 in support of Regulations…
EMDN is online!
The European Commission has released and opened for consultation the first (English) version of the…