The MDCG has released a new Guidance note on how to implement the MDR / IVDR requirements related to the Unique Device Identification (UDI) system…
MDR: 21 Notified Bodies on NANDO!
The NANDO database newly lists 21 Notified Bodies under the MDR! KIWA CERMET ITALIA S.P.A. has been the latest NB notified under the Regulation (EU)…
MDCG Explanatory note on IVDR codes
The MDCG has issued its 2021-14 Guidance related to assignment of codes to in vitro diagnostic medical devices, which is done by the manufacturer when…
MDCG Q&A on EUDAMED Actor registration for importers (update)
The MDCG has released a revised version of Questions & Answers document clarifying actor registration obligations in accordance with MDR Article 31 and IVDR Article…
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 Medical Device Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746…
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 with MDR Article 31 and IVDR Article 28. Some terms,…
IVDR: 5th Notified Body on NANDO!
The NANDO database is richer for a new Notified Body under the IVDR! DEKRA Certification B.V. is the 5th EU Notified Body notified under the…
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 on the implant card of an implantable medical device as…
IVDR Joint Implementation Plan: Priority actions
Following the challenges encountered by the whole sector in the implementation of the IVDR, the Medical Device Coordination Group (MDCG) has released a Joint Implementation and preparedness plan for Regulation (EU) 2017/746…
MDCG on EMDN & IMDRF (UDI)
The MDCG has endorsed two new documents today! The first FAQ MDCG 2021-12 lays down questions and answers on the EMDN (European Medical Device Nomenclature)…