Data mining is a set of advanced techniques and methods used to analyse huge amounts of data, with the aim...
Legislative Decree 4 September 2024, no. 138, adopting Directive (EU) 2022/2555 (NIS 2), introduces important obligations on the subject of...
The certification according to the MDR Regulation (Medical Device Regulation) requires a series of complex phases, that must be followed...
Guideline MDCG 2023-3 Rev.2 is an important update in the landscape of the regulation on medical device and in vitro...
Just as Regulation (EU) 2023/607 had granted a transition period to comply with the requirements of Regulation (EU) 2017/745 on...
In the sector of medical devices, ensuring safety and efficacy is not limited to the design and manufacturing phase only....
Seven years after the European IVDR regulation (Regulation on in vitro diagnostic medical devices) and MDR regulation (Regulation on medical devices)...
Regulation EU 2017/745 on medical devices (Medical Device Regulation, “MDR”) regulates all types of medical devices, including active implantable devices,...
A new deadline is getting close in the world of medical devices (MDs) and in vitro diagnostics (IVDs). As of...
The latest call to the European Commission by all most important European association of the biomedical sector (read here our...
