| • | Authorized Representative Services |
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Manufacturers located outside the EU need an Authorized Representative located within the EU, in accordance with the European Directives. MediTech will act as your main point of reference for the Competent Authorities and the European Commission. This includes the provision of an interface with the Competent Authorities for vigilance reporting.
Services which MediTech offers our clients include conformity assessment, the
preparation of applications to Notified Bodies, notification of clinical investigations to the respective Competent Authority (serving as the manufacturer's representative responsible for placing devices on the market), maintenance of clinical reports required by Competent Authorities, and retention of all technical documentation and certificates so that they are readily accessible locally (Europe) to both Competent Authorities and Notified Bodies.