On 14 April 2025, Team-NB – the European Association of Medical Devices Notified Bodies – published three position papers addressing different crucial aspects of medical…
IVDR: 14th Notified Body on NANDO!
The NANDO database has a new Notified Body under the IVDR! Centro Nacional de Certificación de Productos Sanitarios is the 14th EU Notified Body notified…
MDR: 45th Notified Body on NANDO!
The NANDO database has a new Notified Body under the MDR! TÜV SÜD Danmark is the 45th EU Notified Body notified under Regulation (EU) 2017/745…
2024: Which MDCG guidance can we expect?
The European Commission has released the updated document on the ongoing work of the MDCG and its subgroups. We present you below some of the…
Notified Bodies survey on MDR/IVDR certifications and applications – March update
The European Commission has released updated data from the survey conducted among Notified Bodies on certifications and applications under the Medical Devices Regulation (MDR) and…
MDR: 44th Notified Body on NANDO!
The NANDO database has a new Notified Body under the MDR! RISE Medical Notified Body AB is the 44th EU Notified Body notified under the…
IVDR Joint Implementation Plan has been published!
The Medical Devices Coordination Group (MDCG) has issued a joint implementation and preparedness plan for the In Vitro Diagnostic Medical Devices Regulation (IVDR). This plan…