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…
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 IVDs classified as Class D under the In Vitro Devices…
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The end of the Mutual Recognition Agreement On May 26, 2022, the new Regulation 2017/746 (IVDR) repealed Directive 98/79/EC on in-vitro diagnostic devices (IVDD), which…
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…
MDCG & CAMD: Time to act towards MDR compliance
The Medical Device Coordination Group (MDCG) has issued this June 2022, a position paper on the need for manufacturers to ensure timely compliance with MDR…
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. Specifically, the Regulations involved are the Regulation on clinical trials for…
New Version of the Italian CND is now available!
On January 24, 2022, the Italian Official Journal published the Decree aiming to amend and update the Medical Device National Classification (CND). The CND groups…
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…