Medical Device Technical File and Post-Marketing Surveillance
The technical file is a collection of information and documents that describe in detail the medical device under consideration and in particular the aspects related to the safety and efficacy of the product, starting from the design phase up to post-marketing surveillance . The technical file also describes all the possible solutions taken by the manufacturer to ensure maximum safety of the device. This document must always be updated and, with the exception of class I DMs, IVDs included in Annex II and self-diagnostics, subjected to evaluation by a Notified Body in order to obtain the CE marking , a fundamental requirement for the marketing of DMs. in the European market. Once the medical device has been placed on the market, the competent national authorities have the right to view the technical file, regardless of the classification of the DM, at any time. Furthermore, an incomplete or inadequate technical dossier could lead to delays in market entry or a ban on the rele