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 release of the product.

Regulatory Affairs supports many Italian and international companies in the certification process aimed at obtaining the CE marking. In particular, in order to obtain the CE marking, it deals with the creation of the technical file and all the activities connected to it:

We Support the manufacturer in collecting and producing the necessary documentation

Maintain relations with the analysis laboratories, with the Notified Bodies and with any production workshops

Review all existing documentation to support compliance with the applicable essential requirements of the Directive

• Identify the applicable standards based on the type of product
• Identify the tests / analyzes to be performed on the DM
• Support the manufacturer in identifying and assessing risks
• Review / prepare labels and instructions for use
• Develop / update and implement a risk management process
• Draw up the clinical evaluation according to European guidelines
• Design and creation of mock-ups of primary and secondary packaging

Visit our website for more information about us and our various regulatory services.