The Medical Device Coordination Group (MDCG) released a new position paper on the transition to…
MDR: 32 Notified Bodies on NANDO
The NANDO database newly listed 32 Notified Bodies under the MDR! BUREAU VERITAS ITALIA S.P.A.Viale…
Team-NB: Notified body approach for multiplex IVDs
Team-NB, the European Association of Medical Devices of Notified Bodies, published a position paper on…
MDR: 31 Notified Bodies on NANDO
The NANDO database newly listed 31 Notified Bodies under the MDR! AGENCIA ESPAÑOLA DE MEDICAMENTOS…
European Reference Laboratories: criteria, tasks, and fees
The new Regulation on in vitro diagnostic medical devices brought many changes in the IVD…
MDR: 30 Notified Bodies on NANDO
The NANDO database newly listed 30 Notified Bodies under the MDR! Berlin Cert Prüf- und…
MDR: 29 Notified Bodies on NANDO
The NANDO database newly listed 29 Notified Bodies under the MDR! TUV NORD Polska Sp.…
What is a significant change? New MDCG Guidance for IVD legacy devices
The new Regulation on in vitro medical devices (IVDR) will start to apply on May…
IVDR: 7th Notified Body on NANDO!
The NANDO database has a new Notified Body under the IVDR! 3EC International a.s. is the…
EUDAMED: NB, Certificates & UDI/Device registration – Useful documents
Notified Bodies and Certificates The European Commission has released updated documents on the technical documentation…