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…
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,…
EU IVDR v. CH IvDO: How are In Vitro Diagnostic Medical Devices regulated on the Swiss market?
The end of the Mutual Recognition Agreement On May 26, 2022, the new Regulation 2017/746…
European Reference Laboratories: criteria, tasks, and fees
The new Regulation on in vitro diagnostic medical devices brought many changes in the IVD…
New Version of the Italian CND is now available!
On January 24, 2022, the Italian Official Journal published the Decree aiming to amend and…
From today, the new IVDR applies!
From May 26, 2022, the new Regulation on in vitro medical devices applies! IVDR fully…