The draft of requirements for technical documentation and IFU

The Russian Ministry of Health published the draft of requirements for technical documentation and user manual (IFU).

This document determines requirements for technical documentation and user manual (IFU) content for Medical Devices including In Vitro Diagnostic Devices. According to this document following procedures can be performed: production (manufacturing), storage, transportation, installation, use, operation, among other things maintenance and repair, recycling or destruction of Medical Devices.

For the purposes of these requirements the basic definitions from Russian Federation order 27.12.2012 N 1416 “State registration rules for Medical Devices” and Eurasian Economic Community acts are used (which were accepted in THE framework of implementation provisions of the Agreement on Common Principles and Rules for Medical Devices Circulation).

BW team HAS analyzed this draft. In our opinion the most important moments are the following:

  1. Technical file should include: risk management file, clinical evaluation, verification and validation documentation. These documents were required before but were not codified.
  2. Manufacturer technical documentation for each Medical Device should contain information allowing to get a general idea of the main design stages and on the production processes.

This information can be presented in the form of a process flow chart (diagram) giving an overview of the design, manufacture, assembly, final testing and final finished Medical Device packaging.

  1. User manual (IFU) can be presented in short version or on the label (for Medical Devices 1 and 2a risk class), if the medical device can be safely used and used as intended specified by the manufacturer. User manual (IFU) can be presented in electronic form, including by posting the information on the screen, which is a Medical Device part or the manufacturer’s information resource in the Internet.