GFI certifies a new Medical Device in Macedonia

Treatment for Vulvovaginal Mycotic Infections: FarmaImpresa Group certifies a new Medical Device in Macedonia We have completed the registration with the competent authorities in Macedonia for a Class I medical device, designed for the treatment of vulvovaginal mycotic infections. The medical device is formulated as a vaginal suppository based on hyaluronic acid, boric acid, and…

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 Regulation: Translation and repackaging activities

With the adoption of European Regulations 2017/745 MDR (Medical Device Regulation) and 2017/746 IVDR (In Vitro Diagnostic Regulation), the regulation for medical devices and in vitro medical devices has changed dramatically. The main objectives of the 2017/745 European MDR (Medical Device Regulation) and IVDR (In Vitro Diagnostic Regulation) are to “establish a robust, transparent, predictable…

The obligations of importers and distributors under MDR

With the adoption of the European Regulations 2017/745 MDR (Medical Device Regulation) and 2017/746 IVDR (In Vitro Diagnostic Regulation), the regulations for medical devices and in vitro medical devices have changed dramatically. With the MDR (Medical Device Regulation), the figures of economic operators were, at last, regulated; figures that were not fully considered in the…

MDR: The new roles of economic actors

Economic players, new definitions, and the roles players can play in the medical device market With the adoption of European Regulations 2017/745 MDR (Medical Device Regulation) and 2017/746 IVDR (In Vitro Diagnostic Regulation), the regulations for medical devices and in vitro medical devices have changed dramatically. With the MDR regulation, the figures of traders were,…