Order No. 686n dated 07 July, 2020 by the Ministry of Health of the Russian Federation

MINISTRY OF HEALTH OF THE RUSSIAN FEDERATION

ORDER

dated July 7, 2020 No. 686n

ON AMENDING ANNEXES No. 1 AND No. 2 TO ORDER No. 4n OF THE MINISTRY OF HEALTH OF THE RUSSIAN FEDERATION DATED JUNE 6, 2012 “ON APPROVAL OF THE NOMENCLATURE CLASSIFICATION OF MEDICAL DEVICES”

Pursuant to subparagraph 5.2.184 of the Regulation on the Ministry of Health of the Russian Federation, approved by Resolution of the Government of the Russian Federation No. 608 dated June 19, 2012 (Collected Legislation of the Russian Federation, 2012, No. 26, Art. 3526), I hereby order:

1. To approve the attached amendments to Order No. 4n of the Ministry of Health of the Russian Federation dated June 6, 2012, “On Approval of the Nomenclature Classification of Medical Devices” (registered by the Ministry of Justice of the Russian Federation on July 9, 2012, Registration No. 24852), as amended by Order No. 557n of the Ministry of Health of the Russian Federation dated September 25, 2014 (registered by the Ministry of Justice of the Russian Federation on December 17, 2014, Registration No. 35201).
2. To establish that this Order shall not apply to legal relations concerning the state registration of medical devices where the application for state registration or the application for amendments to the documents contained in the registration dossier of a medical device was submitted by the applicant to the Federal Service for Surveillance in Healthcare prior to the date of entry into force of this Order.

Minister

M. A. MURASHKO

APPROVED

by Order No. 686n of the Ministry of Health
of the Russian Federation
dated July 7, 2020

AMENDMENTS TO ANNEXES No. 1 AND No. 2 TO ORDER No. 4n OF THE MINISTRY OF HEALTH OF THE RUSSIAN FEDERATION DATED JUNE 6, 2012 “ON APPROVAL OF THE NOMENCLATURE CLASSIFICATION OF MEDICAL DEVICES”

1. In Annex No. 1 to the Order:
1) Clause 5.3 shall be declared invalid;
2) Annex No. 1 shall be supplemented by Clause 20 as follows:

20 Software that is a medical device

2. In Annex No. 2 to the Order:

1) In Section I:

a) in the title of the Section, after the words “for in vitro diagnostics”, add the words “and software that is a medical device”;

b) Clause 7 shall be declared invalid;

2) In Section II:

a) in the title of Section II, after the words “for in vitro diagnostics”, add the words “(except for software that is a medical device)”;

b) Clause 12 shall be declared invalid;

3) Section III shall be added as follows:

III. Classification of Software That Is a Medical Device

13. When classifying software that is a medical device (hereinafter referred to as “software”), each software product may be assigned to only one class of potential risk of use:

Class 1 — software with a low degree of risk;

Class 2a — software with a medium degree of risk;

Class 2b — software with an increased degree of risk;

Class 3 — software with a high degree of risk.

The assignment of a class of potential risk of use to software pursuant to this Clause shall be made irrespective of the class of potential risk of use of the medical device in combination with which the software is used.
14. Software shall be classified based on the following criteria:
14.1. Assignment to one of the types of information shall be based on an assessment of the degree of influence of the results obtained through the use of the software:
14.1.1. Type 1 information. This type includes information that does not require clarification and/or supplementation for making a justified clinical (medical) decision and indicates the need for immediate and timely action.
14.1.2. Type 2 information. This type includes information that requires clarification and/or supplementation for making a justified clinical (medical) decision.
14.1.3. Type 3 information. Information that does not indicate the need for immediate action.
14.2. Conditions of use of the software (Assignment to a category shall be based on the intended purpose of the software):
14.2.1. The conditions of use of the software shall fall under Category “A” if the software is intended:
• to provide emergency medical care;
• for use during surgical intervention and/or comprehensive therapy and/or to determine the need for such intervention or therapy;
• for the diagnosis and/or treatment of a disease or diseases or patient conditions that present a high public health risk and/or a high individual risk.
Use of the software under Category “A” conditions shall be permitted only by a healthcare professional who has undergone the necessary training in the use of the software.
14.2.2. The conditions of use of the software shall fall under Category “B” if the software is intended:
• to provide urgent medical care;
• to provide medical care without surgical intervention;
• for the diagnosis and treatment of a disease or diseases or patient conditions that present a moderate public health risk.
Use of the software under Category “B” conditions shall be permitted only by a healthcare professional who has undergone the necessary training in the use of the software.
14.2.3. The conditions of use of the software shall fall under Category “C” if the software is intended:
• to provide scheduled medical care;
• to provide medical care using non-invasive methods and/or for use in long-term care;
• for the diagnosis or treatment of a disease or diseases or patient conditions that present a low public health risk.
Use of the software under Category “C” conditions shall be permitted both by a healthcare professional and by a patient or another individual upon prescription and/or under the supervision of a healthcare professional.
15. When assigning software to classes depending on the potential risk of use, the types of information and the conditions of use of the software shall be taken into account:
15.1. If the software is intended for use under conditions falling under Category “A”, and the information obtained using the software is Type 1 information, the software shall be assigned to Class 3.
15.1.1. Software using artificial intelligence technologies <1> shall be assigned to Class 3.
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<1> Pursuant to Decree of the President of the Russian Federation No. 490 dated October 10, 2019, “On the Development of Artificial Intelligence in the Russian Federation” (Collected Legislation of the Russian Federation, 2019, No. 41, Art. 5700).
15.2. Software shall be assigned to Class 2b if it:
15.2.1. It is intended for use under conditions falling under Category “A”, and the information obtained using the software is Type 2 information;
15.2.2. It is intended for use under conditions falling under Category “B”, and the information obtained using the software is Type 1 information.
15.3. Software shall be assigned to Class 2a if it:
15.3.1. It is intended for use under conditions falling under Category “A”, and the information obtained using the software is Type 3 information;
15.3.2. It is intended for use under conditions falling under Category “B”, and the information obtained using the software is Type 2 information;
15.3.3. It is intended for use under conditions falling under Category “C”, and the information obtained using the software is Type 1 information.
15.4. Software shall be assigned to Class 1 if it:
15.4.1. It is intended for use under conditions falling under Category “B”, and the information obtained using the software is Type 3 information;
15.4.2. It is intended for use under conditions falling under Category “C”, and the information obtained using the software is Type 2 or Type 3 information.
16. If, when assigning software to a class depending on the potential risk of use, a combination of different types of information obtained using such software and/or categories of conditions under which it is used is possible, the software shall be assigned the class corresponding to the highest degree of potential risk of use.”