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.…
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…