Find below the replies from 22 (out of 24) NB members in the most recent study organized by the Team-NB concerning the 2018 and wished…
EMA Q&A on Article 117 of MDR: Medicines with medical device component
Last Friday, European Medicines Agency (EMA) published first guidance on the implementation of the Article 117 of the Medical Devices Regulation (MDR) that requires intervention…
CND nomenclature selected for the future EUDAMED!
Under Article 26 of the MDR, the European Commission was tasked to make available an internationally recognised medical devices nomenclature that will be free of…
European Commission update on the MDR implementation
Today, at a conference in Brussels, the European Commission shared important points and dates regarding the MDR implementation and preparedness of the regulatory framework, and…
MDCG Position on Content of the certificates, voluntary certificate transfers just published!
The MDCG endorsed a Position document – Guidance on content of the certificates, voluntary certificate transfers where it discussed: Content of the certificate under MDR…
NBs on Classification Rule 8 of the MDR
NB-Med and Team-NB issued a Joint Position Paper to ensure more harmonized classification of implantable devices and long-term surgically invasive devices under the new MDR…
MDCG guiding principles for issuing entities: Basic UDI-DI
MDCG (Medical Device Coordination Group) stated in the newly published guiding principles for issuing entities rules that the Basic UDI-DI requirements on format should be…
NEW eBOOKS: How will the new Regulations (MDR/IVDR) impact you?
We are happy to announce the below two new publications that were added to our MDlaw e-shop! MDR eBOOK IVDR eBOOK In approximately 200 pages,…
First NB designated under the MDR !
The European Commission announced the designation of the first Notified Body under the new Regulation on Medical Devices in the NANDO database! The first NB…
IVDR: Team-NB Survey on NB designation process
This time, Team-NB performed a survey on the designation process of Notified Bodies (NBs) under the IVDR and currently: From 20 Team-NB notified bodies…