DECISION OF BOARD OF THE EURASIAN ECONOMIC COMMISSION

of May 23, 2023 No. 65

About modification of Rules of classification of medical products depending on potential risk of application and about recognition voided some Decisions of the Eurasian economic commission

According to item 4 of article 4 of the Agreement on the single principles and rules of the address of medical products (products of medical appointment and medical equipment) within the Eurasian Economic Union of December 23, 2014 and Item 23 of appendix No. 2 to the Regulations of work of the Eurasian economic commission approved by the Decision of the Supreme Eurasian economic council of December 23, 2014 No. 98, Board of the Eurasian economic commission solved:

1. Bring in the Rules of classification of medical products depending on potential risk of application approved by the Decision of Board of the Eurasian economic commission of December 22, 2015 No. 173, of change according to appendix.

2. Determine that Item 1 of this Decision does not extend to the legal relationship connected with registration of medical products if statements for holding procedures of registration and examination, modification of the registration file (including in notifying procedure) or about carrying out approval of the expert opinion on the registered medical product were submitted by the applicant about day of entry into force of this Decision.

3. Recognize invalid:

a) The decision of Board of the Eurasian economic commission of July 24, 2018 No. 116 "About Criteria of differentiation of the elements of medical product which are components of medical product for the purpose of its registration";

b) The decision of Board of the Eurasian economic commission of July 24, 2018 No. 123 "About Criteria of inclusion in one registration certificate of several modifications of medical product relating to one type of medical product according to the nomenclature of medical products applied in the Eurasian Economic Union".

4. This Decision becomes effective after 180 calendar days from the date of its official publication.

Appendix

to the Decision of Board of the Eurasian economic commission of May 23, 2023 No. 65

The changes made to Rules of classification of medical products depending on potential risk of application

Rules of classification of medical products depending on potential risk of application to state in the following edition:

"Are approved by the Decision of Board of the Eurasian economic commission of December 22, 2015 No. 173

Rules of classification of medical products depending on potential risk of application

I. General provisions

1. These rules are developed for the purpose of implementation of the Agreement on the single principles and rules of the address of medical products (products of medical appointment and medical equipment) within the Eurasian Economic Union of December 23, 2014 and establish procedure for classification of medical products depending on potential risk of the harming which is expressed in injuring or drawing damage to health of patients from application of medical products, the personnel operating medical products, other persons, to public health or the environment.

2. These rules extend to the medical products released within the Eurasian Economic Union.

3. For the purposes of these rules concepts which mean the following are used:

"active diagnostic medical products" - the active medical products intended for submission of information for the purpose of diagnostics, control of treatment or change of physiological condition, condition of disease or birth defects;

"active medical products" - the medical products applied separately or in combination with other medical products which action requires energy use, excellent from made by the person or gravity. The medical products intended for transmission of energy or substances from active medical product to the patient without their essential change are not active medical products;

"active therapeutic medical products" - the active medical products intended for preserving, change, replacement or recovery of the biological functions or structures connected with treatment, simplification of disease, wound or disability;

"anolyte" - test component with measurable property;

"аферез" - the method of receipt of separate components of blood subdivided into plasmapheresis and cytapheresis;

"the implanted medical products" - the invasive medical products including in parts or in full resolving in organism, which are completely entered into body of the person or replacing the epithelial surface or the surface of eye by means of surgical intervention and remaining in the place of introduction after the surgical procedure and also the medical products which are partially entered into body of the person by means of surgical intervention and remaining in the place of introduction after the surgical procedure more than 30 days;

"invasive medical products" - the medical products intended for complete or partial introduction in body of the person through its surface or through body opening;

"artificial intelligence" - the complex of technology solutions allowing to imitate cognitive functions of the person (including self-training and finding solutions without in advance set algorithm) who includes information and communication infrastructure, the software (including with use of methods of machine training), processes and services for data processing and finding solutions;

"medical products for temporary application" - the medical products intended for continuous application during certain time (from 60 minutes to 30 days) according to the instruction for application or the operation manual;

"medical products for prolonged use" - the medical products intended for continuous application within more than 30 days according to the instruction for application or the operation manual;

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