The MDCG has released a new Guidance note on how to implement the MDR /…
MDR: 21 Notified Bodies on NANDO!
The NANDO database newly lists 21 Notified Bodies under the MDR! KIWA CERMET ITALIA S.P.A.…
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…
Manufacturers of implantable medical devices: new MDCG guidance on implant card!
The MDCG has released a very important guidance on the ”device type” to be shown…
MDCG on EMDN & IMDRF (UDI)
The MDCG has endorsed two new documents today! The first FAQ MDCG 2021-12 lays down…
3 days under the MDR & new MDCG Position Paper on UDI
26 of May 2021 was probably the most important day of 2021 for the medical…
Clinical investigation application/notification under MDR: MDCG provides important templates
The Medical Device Coordination Group (MDCG) has endorsed a document on the topic of clinical…
Switzerland & MDR DoA: Update
In the light of the approaching MDR date of application (26 May 2021) without the…