A webinar held on 8th May took the stock of the situation of the serialization for drug traceability, provided for...
Regulation (EU) 2023/607 has amended Regulation (UE) 2017/745 (MDR) extending the transitory period and defining the criteria to benefit from...
A meeting was held on 17 April 2024 in the hall of the “Last Supper” at the Italian Chamber of...
Eudamed: european database of medical devices. It is the unique database of medical devices and it is intended to collect...
For a Medical Device and In Vitro Diagnostics manufacturer, keeping up with continuous legislation changes that characterize this sector at...
You’ll find below some basic information and simple recommendations for the MAHs of NAPs (NP/MRP/DCP authorised products) on the above...
Regulation (EU) 2023/607 was published a year ago, changing articles 120, 122 and 123 of Regulation (EU) 2017/745 (MDR), further...
What are custom-made medical devices? A custom-made medical device is defined as follows: “any device specifically made in accordance with...
The requirements to obtain the conformity with Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746 (IVDR) include something new compared...
