In September 2022, the Medical Devices Coordination Group (MDCG) issued a manual addressing borderline and classification under the Medical Devices Regulation (MDR) and the In Vitro Diagnostic…
Call for EU reference laboratories to Member States
In July 2022, the European Commission opened its call for Member States to submit applications for EU reference laboratories. The call is for EU Member…
Team-NB: Notified body approach for multiplex IVDs
Team-NB, the European Association of Medical Devices of Notified Bodies, published a position paper on the approach to the Technical Documentation assessment of multiplex IVD…
Implementation Rolling Plan July 2022 (MDR/IVDR)
The European Commission released an updated Implementation Rolling Plan under the Regulations 2017/745 and 2017/746 with the list of implementing acts and actions to take…
Practices and alternatives until EUDAMED is fully functional
The new Regulations on medical devices (MDR) and in vitro medical devices (IVDR) introduced EUDAMED, a new traceability system for medical devices on the EU…
EUDAMED Delayed!
The European Commission has announced a delay of the full functionality of the European database on medical devices (EUDAMED) and a new update of the…
European Reference Laboratories: criteria, tasks, and fees
The new Regulation on in vitro diagnostic medical devices brought many changes in the IVD sector. In line with stricter assessment procedures, the Regulation introduced…
From today, the new IVDR applies!
From May 26, 2022, the new Regulation on in vitro medical devices applies! IVDR fully applies from May 26, 2022 CE Certificates issued under the…
IVD: What is the status of the Mutual Recognition Agreement between the EU and Switzerland?
From May 26, 2022, the agreement between Switzerland and the European Union on mutual recognition for the market of in vitro diagnostic medical devices will…
IVDR: Harmonised standards for QMS and risk management
May 26, 2022, is an important date for all stakeholders of the IVD sector. The new Regulation on in vitro diagnostic medical devices (IVDR) will…