The NANDO database newly lists 22 Notified Bodies under the MDR! EUROFINS PRODUCT TESTING ITALY S.R.L. has been the latest NB notified under the Regulation (EU)…
First harmonised standards under MDR& IVDR are now available!
The European Commission has published in the Official Journal of the European Union (OJEU) the Commission Implementing Decision (EU) 2021/1182 of 16 July 2021 on…
MDCG Guidance note: UDI within organization’s QMS
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 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,…
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…
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…