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...
We are now in year 8 of our coexistence with the (no more) new European Regulations 2017/745 and 2017/746 that, as of their...
For a Medical Device and In Vitro Diagnostics manufacturer, keeping up with continuous legislation changes that characterize this sector at...
Regulation (EU) 2023/607 was published a year ago, changing articles 120, 122 and 123 of Regulation (EU) 2017/745 (MDR), further...
Article 61 of the MDR defines the requirements to carry out a clinical evaluation of a medical device. Further clarifications...
