The Medical Devices Coordination Group (MDCG) has released this August a guidance on the designation,…
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…
The European Commission lays down common specifications for Class D IVDs!
The European Commission has adopted the Commission Implementing Regulation setting out common specifications for some…
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…
MDCG & CAMD: Time to act towards MDR compliance
The Medical Device Coordination Group (MDCG) has issued this June 2022, a position paper on…
Clinical trials for medicinal products and IVDs: interface between two Regulations
The Medical Device Coordination Group (MDCG) published a Q&A document on the interfaces between two Regulations.…