Technical File Instruction

The manufacturer of a medical device, in order to demonstrate the conformity of its products with the requirements of the Directive DM 93/42 /EEC and subsequent amendments thereto, and in the near future, to the new EU Medical Device Regulation 745/2017, must prepare a technical dossier to be kept and made available to the Competent Authority and Notified Body, if the device is of a class higher than I.
The technical bundle can be produced following various standards and document models (STED, TOC, etc.). In 2018 IMDRF issued a new dossier format for TOC files.
A Technical file in TOC format will certainly allow the manufacturer an easier reuse of the documentation already developed and to register its products on international markets.
Maytal consultants can collect project outputs and draft the technical dossier, support the company in defining the structure of the technical dossier.
The drafting of the technical dossier assumes that the company already has all the project outputs required for the preparation of the Technical dossier (eg software validation, clinical validation, usability validation, etc.).