Updated Requirements for Technical and Operational Documentation of Medical Devices

By Order No. 181 of the Ministry of Health dated April 11, 2025, the requirements for the technical and operational documentation of medical devices have been updated.

The new requirements will come into force on September 1, 2025, and will remain valid until September 1, 2031. They replace the current Order No. 11n dated January 19, 2017.

As part of the technical documentation submitted in the registration dossier, the manufacturer or its authorized representative must now include the following:

• Device name and other identification information
• Intended use and principles of operation
• Indications and contraindications
• Information on potential users
• Technical specifications
• Description of main functional components
• Description of subassemblies
• Description of accessories
• Confirmation of lack of interchangeability limitations
• List of identified risks and risk management methods
• Verification and validation data
• Compatibility information with devices from other manufacturers
• Information on contact with human body surfaces, mucous membranes, or internal environments
• Labeling and packaging details
• Information on animal- or human-derived materials
• Evidence materials supporting the manufacturer’s claims
• Details on previous modifications of the device
• Information on major design stages and production processes
• Documents confirming the quality of pharmaceutical substances and materials used
• Sterilization methods
• Maintenance and repair requirements
• Disposal or destruction instructions

Additional Requirements for In Vitro Diagnostic Medical Devices (IVDs)

• Intended use including:
  • Target analysis
  • Functional purpose
  • Specific pathology or risk factor
  • Sample type
  • Population/demographic aspects
• User qualification level
• Analytical method and device operating principle
• Technical specifications
• Transport and storage conditions
• Analytical sensitivity
• Measurement procedures and metrological traceability of calibrators and control materials
• Device stability data

Software as a Medical Device

For software classified as a medical device, documentation must now also include:

• Information on the use of artificial intelligence (AI) technologies
• Automated synchronization methods
• Multi-level authorization and access rights differentiation

Important:

All documentation issued before the new rules come into force must be updated to comply with the new requirements. This update is mandatory when making changes to a medical device’s entry in the national medical device registry.

The conformity assessment of medical devices and pharmaceuticals is a mandatory procedure for the state supervision of these products.
This procedure is intended to verify whether the safety and quality requirements are met.
Following the conformity assessment, a certificate is issued in the form of a
state registration of medical devices and pharmaceuticals.

How Can We Help?

In this rapidly evolving regulatory environment, Schmidt & Schmidt offers comprehensive support for exporters to EAEU countries. Our range of services includes EAC certification, adaptation to specific product categories, and customized solutions to meet the technical and legal requirements of these markets. We are committed to making market entry and expansion in these regions easier for companies by providing up-to-date information and guidelines.

Technical expertise, attention to detail, and accuracy in document preparation are essential for the smooth distribution and use of products, machinery, or equipment within the EAEU. Technical documentation must also be written in Russian or the official language of the member country in which the product is sold or used. To avoid any issues, we are happy to assist you in preparing new technical documentation or reviewing existing documents for completeness and linguistic and terminological accuracy in Russian.

Thanks to their many years of experience, our experts can also offer you specific industry knowledge in the fields of plant engineering, mechanical engineering, metalworking, metrology, electrical engineering, automation, medical technology, food processing, and the furniture industry.