Frequently asked questions in the MDR field

In this article we are going to analyze the questions and answers regarding the new European Regulation 2017/745 or MDR (Medical Device Regulation). Recall that we are among the first Italian companies to have obtained MDR certifications for some of our medical devices.   How are economic operators regulated in the new MDR regulation? In…

MDR regulations: the technical file

When is a change in a medical technical file considered significant under Art. 120(3)MDR? A Medical Device Manufacturer with a valid certificate issued by a Notified Body under Directive 90/385/EEC (AIMDD) or Directive 93/42/EEC (MDD) may place its devices on the market even after May 26, 2021 (date of full implementation of MDR (EU) 2017/745)…