The Roszdravnadzor, the Russian federal authority responsible for medical devices regulation, issued recommendations on quality, effectiveness, and safety examination of medical software for the purpose of state registration under the national framework.
Eligibility Assessment of Medical Software
The Roszdravnadzor describes the approach to be used to determine whether the software in question meets the definition of medical device and thus should be regulated accordingly.
According to the Roszdravnadzor guidelines, the software should be determined as a medical device in case if it meets all the following criteria:
- It is a software or a module and also on the type of software deployment and access,
- Is not a part of any other medical device,
- Is intended by the manufacturer to provide medical care,
- The result of operations performed by the software is the interpretation in automated mode (including with the help of AI) or in accordance with the pre-defined parameters impacting on clinical decisions, of the data collected from medical devices allowed to be used in accordance with the general procedure.
At the same time, to avoid any doubts, the Roszdravnadzor provides the examples of technologies and functions used in software that do not constitute the interpretation of data:
- Displaying data received from a medical device,
- Calculation based on pre-defined formulas,
- Conversions between measuring units,
- Building statistical charts and reports,
- Editing images,
- Alerts notifying on changes in data when the initial data available and the parameters could be defined by the user,
- Features allowing to create forms, business processes, reports, or other visual representations.
To assist medical device manufacturers (developers of medical software) in applying the rules described therein, the authority provides several examples of software as a medical device (SaMD), such as the software for viewing the individual anatomic 3D model based on the computer tomography, intended to be used by healthcare professional. Such software meets any and all aforementioned criteria, namely:
- Interpretation function –calculation of the distance between two points of the anatomic model,
- The initial source of data – computer tomograph
- Intended purpose – to be used by doctors, including when providing emergency care,
- Platform – mobile devices (e.g. smartphone or tablet),
- Method of providing access – app store.
To ensure correct interpretation of rules stated in the present Roszdravnadzor guidelines on medical software, the authority also provides the examples of the software that shall not be deemed as a medical device. The examples of excluded software include, inter alia, the following ones:
- Software intended for general administrative purposes,
- Software intended for general wellness purposes to engage people to carry out a healthy lifestyle, providing that such software calculates calories, number of steps, weight, and height, etc.,
- Medical informational systems utilized by healthcare organizations and laboratories, the software intended to keep records and medical cards, systems intended for archiving and sending images, proving that such software does not contain the interpretation feature,
- Software and updates thereto used to operate medical devices and control its operability,
- Software that utilizes data received from one or several medical devices, but not intended to provide medical care (for example, the software that encrypts and(or) accumulates data collected from one or several medical devices for further transmission,
- Software intended to transmit text or voice messages, electronic documents, photographic images, videos, audio- recordings or streams, or other data between the healthcare professional and patient, the registration of such data, its storing and providing access thereto when providing medical care, including with the help of telemedicine.
- Software intended for keeping records on maintenance and service of medical devices,
- Software for the unlimited circle of users, intended to be used for educational, scientific, and informational purposes, including when used to choose a healthcare professional.
Intended Purpose of the Medical Software
According to the Roszdravnadzor guidelines on software as a medical device, the intended purpose of the software subject to review as indicated in the application for registration submitted by the medical device manufacturer (developer), and its compliance with the information contained in technical and operational documentation, shall be checked at one of the first steps of the assessment process.
When evaluating the intended purpose of the SaMD in question, the Roszdravnadzor will consider the following criterion of incompliance: the description of the intended purpose is not detailed enough, including cases when the information regarding the use of the software for medical purposes is absent.
Software a Medical Device Classification
When reviewing the application, the Roszdravnadzor will also check the type of the software in accordance with the valid classification. In the case of incompliance, the expert performing the review will determine another type of medical device in accordance with the applicable classification rules.
The Roszdravnadzor states that the particular class of the device should be determined and indicated in accordance with the risk-based classification depending on the risk associated with the use of the SaMD for the intended purpose indicated by the medical device manufacturer (developer). The authority additionally emphasizes that the special medical software that constitutes an independent product and used together with the medical device, the determined class under the risk-based classification should be the same as for the medical device itself.
In accordance with the State Standard 62304-2013, the manufacturer (developer) of a medical software shall assign the appropriate class under the risk-based classification depending on the potential impact the software could cause to the patient, and the particular threats associated thereto.
Depending on the risk associated with the use of the software, it could be divided into the following classes:
- Class A: no risk of injury or threat to the health of the patient,
- Class B: certain minor injuries possible,
- Class C: serious injuries possible.
In a case, if the threat arises from the malfunctions in operations of the medical software system, the probability of such malfunction shall be deemed as 100%. For the purpose of this rule, the system is a composition consisting of one or more processes, technical means, software, people, and measures, that ensure that the intended purpose will be met.
Evaluation of the Technical Documentation
The present Roszdravnadzor guidelines also contain information regarding the way the technical documentation should be assessed and evaluated. In particular, the authority states that the technical documentation accompanying medical software as a part of the application for medical software registration in Russian Federation shall contain the information about the process of design, development, and validation of the software used in a medical device (in case the device contains software ensuring its correct use for the intended purpose).
The authority also states that the technical documentation will be found incompliant in a case if it lacks the information on:
- Construction of a medical device (description of its components and connections existing between them),
- Technical requirements used for design, development and manufacturing the medical software,
- Measures taken by the medical device manufacturer (developer) to address risks associated with cybersecurity,
- Quality and sufficiency of the measures implemented by the manufacturer to ensure the protection of the information.
Summarizing the information provided here above, the new Roszdravnadzor guidelines describe the approach to be applied when evaluating medical software submitted for the state registration.
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