Medical Device Consulting: Authorized Representative in the European Union.
I3CGLOBAL makes the EUROPEAN AUTHORIZED REPRESENTATIVE service for medical devices available to its non-EU customers. All medical devices (including active and in vitro) manufactured outside the European Union must have an authorized representative in the European Union based in any member state who must be appointed by the medical device manufacturing company in writing. This representative must carry out the obligations contained in the European regulations on medical devices, Directive 93/42/EEC on medical devices and Regulation 2017/745 on medical devices. The EU authorized representative must be communicated to the authorities at the time of notification of placing on the market of class IIa, IIb and III medical devices. This company responsible for medical devices marketed in the European Union must act as an interlocutor for the community health authorities and have at their disposal all the information related to imported medical devices at the headquarters communicated in a me