Official Representation in Europe for MedTech Companies
Medicina Legatis ensures your European representation, and this in the heart of Europe, Belgium. It means that Medicina Legatis helps its non-European medtech clients in the introduction in Europe of their medical device(s), acting as their authorized representative for verification and managing of the whole documentation necessary to demonstrate conformity to the General Safety and Performance Requirements (GSPR). When the medical device is on the European market, the European representative cooperates with the authorities on any preventive or corrective action taken to eliminate (or at least mitigate) the risks posed by the medical device. Furthermore, also in the case of a clinical investigation conducted in Europe, the manufacturer needs to appoint its European representative. Medicina Legatis offers your company its services of Authorized Representation.
Medicina Legatis is solely active in medical devices, which does not include in vitro diagnostic medical devices, submitted to other rules and obligations. Medicina Legatis does not act neither as notified body, nor as importer or distributor, nor as Contract Research Organization (CRO). Medinica Legatis works only in English and all documents of its clients manufacturers need to be in that language (in case of an action initiated by a member state in another language, Medicina Legatis will handle the problem using certified translators).