Russian Ministry of Healthcare has issued an amendment to the regulation 4N dated June 6, 2012, on the classification of medical products. The amendment implements special rules to be applied to software with an intended medical purpose (medical software). The amended regulation does not cover medicinal products, for which the applications for registration or changes to the registration dossier have been filed before the present amendment took effect.
Medical Software: Key points
The amendment introduced a new category “Software as a medical device” and repealed the “Software of in vitro diagnostic” category.
The changes to the initial regulation include, inter alia, the following ones:
- the classification rule stating that special software that is an independent product used together with the medical device should be assigned to the same class as the medical device itself has been repealed in both classification sections (for classical and in vitro diagnostic medical devices),
- the software has been also explicitly excluded from the scope of both aforementioned sections.
- an entirely new section has been added: Classification of the software that is a medical device.
Medical Software Classification Rules
The amendment has also introduced a set of rules to be applied for software as a medical device. According to the amendment, such classification should be based on the potential risk associated with the device. In particular, the following classes should be applied:
- Class 1 – low-risk software,
- Class 2a – moderate risk software,
- Class 2b – elevated risk software,
- Class 3 – high-risk software.
The regulation also states that the appropriate risk class should be assigned to the software as described above irrespectively of the risk class of the medical device the software is intended to be used with.
If due to the nature of the software, several classes are applicable, the software should be assigned to the class with the highest level of associated risk.
Summarizing the information provided hereinabove, the new amendments to the regulation on the classification of medicinal products introduced by the Russian MOH actually intend to implement special classification rules for the software with the intended medical purpose. According to these rules, medical software should be classified on the basis of the associated risk. The main criteria to be considered for the purpose of classification are the information the software provides and specific conditions the software is intended to be used in. Depending on these criteria, the medical software could be assigned to one of the four classes. Another important point relates to potential users: according to the amended regulation, depending on the conditions the software is intended to be used in, it should be used either only by the properly trained healthcare professionals or by other users/patients too. Such restrictions have been introduced in order to ensure correct interpretation of the information provided by the software in the case when such information is being used to make important clinical decisions or provide emergency medical services.
By implementing the aforementioned provision, Russia aligns its regulations on medical devices with international practices providing that software intended to be used for medicinal purposes should be regulated as a medical device due to the importance of the role it could play in diagnosing or treatment. The new classification rules allow for medical software to be assigned to the appropriate class depending on the potential risks resulting from the use of the software.
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