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...
Medical devices are a wide range of products used in the medical field for diagnostic or therapeutic purposes, including syringes...
Article 61 of the MDR defines the requirements to carry out a clinical evaluation of a medical device. Further clarifications...
Drug traceability is a relevant and delicate aspect of pharmaceutical management. In fact, it allows unique identification of every single...
On 3 January 2024, the Legislative Decree of the Ministry of Health no. 218 of 7 December 2023 was published...
