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)…
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 device community in terms of regulatory changes. The Medical Device…
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 investigation application/notification since EUDAMED module for clinical investigations is not…
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…