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…
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)…
Switzerland & MDR DoA: Update
In the light of the approaching MDR date of application (26 May 2021) without the signed Mutual Recognition Agreement (MRA) between Switzerland and the European…
UDI Helpdesk ready for use!
The European Commission has launched the UDI (Unique Device Identification) Helpdesk to provide assistance in implementing the UDI-related requirements of the MDR and IVDR and…
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 (EU) 2017/745 [MDR] and (EU) 2017/746 [IVDR] has been accepted…