Changes in the requirements for medical devices from September 1, 2025 (Order of the Ministry of Health No. 181n)

On September 1, 2025, Order of the Ministry of Health No. 181n comes into force, which will replace the current Order No. 11n of 2017 and introduce significant changes to the requirements for technical and operational documentation of medical devices (MD), including medical software (SW).

1. New requirements for labelingAdditional labeling data must now be indicated in Russian for medical devices manufactured outside the Russian Federation.

2. Tightening of information security requirements for medical software.
The documentation must indicate:
– Use of anti-virus software (if not provided by the manufacturer).
– Use of cryptographic data protection.
– Availability of archiving and backup functions.
– Protection against illegal distribution.

Additional data
It is now required to specify:The data interpretation function.The source of the data set (e.g. clinical trial databases).The hardware platform on which the software runs.The method of software deployment (local, cloud) and access provision.

Clinical guidelines for software algorithms
If the software uses algorithms based on clinical guidelines, this must be reflected in the documentation.

3. New requirements for servicing the MIV documentation must specify:The list of keys, passwords, software for installation and maintenance.The list of consumables and the procedure for their use.The need for calibration (if required).Methods for mitigating risks during installation and maintenance.

4. Transition periodThe documentation prepared in accordance with the old rules (Order No. 11n) must be brought into compliance with the new requirements in case of any changes in the data specified in the registration certificate (RC).


Conclusion
From September 1, 2025, manufacturers and suppliers of medical devices (including software) must: Update labeling and documentation. Take into account new requirements for software information security. Include additional data on the functionality and platform of the software. Specify clinical recommendations if the software algorithms are based on them. Bring the documentation into compliance at the first change in the RU.

It is recommended to prepare for changes in advance to avoid the risk of registration suspension or fines.