Download an MDR 2017/745 Technical File template for free!. This document is a identical copy of the Technical File templates provided by BSI. Using this you will be in full compliance with BSI regulations!
The medical device technical file is a must-have document for devices to be sold in the EU marketplace. The file contains detailed information about your medical device, its design, intended use claims, composition, and clinical evaluations. It’s essentially an “everything you must know” document for a device. If you’re going for a CE Mark, then you need to understand what is required of the technical file.
At a minimum, technical documentation should have:
A device description and specification section. Including UDI
Labeling and instructions for use
Detailed information on design and manufacturing.
Detailed risk management information in compliance with ISO 14971.
General Safety and Performance Requirements (GSPR)
Verification and validation information.
Post-market surveillance (PMS) information, including PMS plan, post-market clinical follow-up (PMCF) plan, and periodic safety update report (PSUR) in the case of Class I devices.
Click below and download an editable MDR Technical File template for free!
