The applicable national implementation in Portugal will be stated under the Decree-Law ensuring the implementation of…
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…
Team-NB: Notified body approach for multiplex IVDs
Team-NB, the European Association of Medical Devices of Notified Bodies, published a position paper on…
Implementation Rolling Plan July 2022 (MDR/IVDR)
The European Commission released an updated Implementation Rolling Plan under the Regulations 2017/745 and 2017/746…
Practices and alternatives until EUDAMED is fully functional
The new Regulations on medical devices (MDR) and in vitro medical devices (IVDR) introduced EUDAMED,…
EUDAMED Delayed!
The European Commission has announced a delay of the full functionality of the European database…
European Reference Laboratories: criteria, tasks, and fees
The new Regulation on in vitro diagnostic medical devices brought many changes in the IVD…
From today, the new IVDR applies!
From May 26, 2022, the new Regulation on in vitro medical devices applies! IVDR fully…