Team-NB has released a new position paper on the best practice guidance for submitting technical documentation…
IVDR: 10th Notified Body on NANDO!
The NANDO database has a new Notified Body under the IVDR! National Standards Authority of…
IVDR: 9th Notified Body on NANDO!
The NANDO database has a new Notified Body under the IVDR! MDC MEDICAL DEVICE CERTIFICATION…
IVDR: 8th Notified Body on NANDO!
The NANDO database has a new Notified Body under the IVDR! QMD Services GmbH. is…
Updated EC Implementation Rolling Plan (MDR/IVDR)
The European Commission released an updated Implementation Rolling Plan under the Regulations 2017/745 and 2017/746…
MDR & IVDR national implementation: Italy
In August 2022, Italy published the national law implementing the EU Regulations on medical devices…
IVD legacy devices: MDCG Guidance on appropriate surveillance
The Medical Device Coordination Group (MDCG) has issued this September 2022 new guidance on the…
MDR & IVDR: Manual on borderline classification issued!
In September 2022, the Medical Devices Coordination Group (MDCG) issued a manual addressing borderline and…
Call for EU reference laboratories to Member States
In July 2022, the European Commission opened its call for Member States to submit applications…
MDCG position paper on Notified Body capacity and availability of medical devices and IVDs!
The Medical Device Coordination Group (MDCG) released a new position paper on the transition to…