DECISION OF COUNCIL OF THE EURASIAN ECONOMIC COMMISSION

of February 12, 2016 №28

About approval of Rules of carrying out technical testing of medical products

According to Item 2 of article 31 of the Agreement on the Eurasian Economic Union of May 29, 2014, Items 4 and 5of 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, Items 105 and 106of appendix №1 to the Regulations of work of the Eurasian economic commission approved by the Decision of the Supreme Eurasian economic council of December 23, 2014 №98, and the Decision of the Supreme Eurasian economic council of December 23, 2014 №109 "About 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" Council of the Eurasian economic commission decided:

1. Approve the enclosed Rules of carrying out technical testing of medical products.

2. This Decision becomes effective after 10 calendar days from the effective date of the Protocol signed on December 2, 2015 on accession of the Republic of Armenia to 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, but not earlier than after 10 calendar days from the date of official publication of this Decision.

Approved by the Decision of Council of the Eurasian economic commission of February 12, 2016 №28

Rules of carrying out technical testing of medical products

I. General provisions

1. These rules establish within the Eurasian Economic Union (further - the Union) procedure for carrying out technical testing of medical products for the purpose of their registration, including requirements to the authorized organizations having the right to carry out technical testing (further - authorized organizations).

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

"testing" - experimental determination of quantity and (or) quality characteristics of properties of object of testing as result of impact on it in case of its functioning, modeling of object and (or) impacts on object;

"test method" - rules of use of certain principles and means of testing;

"technique of testing" - the standard operational procedure including test method, means and test conditions, sampling it (is model), algorithms of accomplishment of transactions by determination of one or several interconnected characteristics of properties of object, form of data presentation and calculation, necessary for receipt of result;

"the program of testing" - the organizational and methodical document establishing object and test objectives, types, methods (techniques) of testing, the sequence and amount of the made experiments, procedure, conditions, the place and terms of carrying out testing.

Other concepts used in these rules are applied in the values determined by acts of bodies of the Union in the field of the address of medical products.

3. Technical testing are carried out for the purpose of establishment of compliance of medical product to General requirements of safety and efficiency of medical products, to requirements to their marking and the operational documentation on them approved by the Decision of Council of the Eurasian economic commission of February 12, 2016 No. 27 (further - General requirements).

4. When carrying out technical testing requirements of the standards included in the list of standards as a result of which application on voluntary basis observance of compliance of medical products to General requirements, and also the declared technical characteristics of medical product which the producer uses for confirmation of conformity of medical product to General requirements is fully or partially provided are applied.

In case of lack of the standards containing rules and methods of researches (testing) and measurements included in the specified list of standards for the purpose of carrying out technical testing methods (techniques) of testing certified (validirovanny) and approved according to the legislation of state member of the Union can be applied (further - state member).

5. Technical testing are carried out in the test laboratories (centers) having the right to carry out technical testing, data on which are included in the unified register of the authorized organizations having the right to conduct researches (testing) of medical products for the purpose of their registration (further - the register of authorized organizations), chosen as the applicant.

Forming and maintaining the register of authorized organizations are performed by the Eurasian economic commission (further - the Commission) according to the Procedure for forming and maintaining information system in the field of the address of medical products approved by the Decision of Council of the Eurasian economic commission of February 12, 2016 No. 30, on the basis of the data represented by the public authorities of state members authorized on implementation and (or) coordination of activities in the field of the address of medical products (further - authorized bodies), with use of means of the integrated information system of the Union.

6. Technical testing are not carried out concerning reagents, sets of reagents, control materials, calibrators, the washing-out solutions and nutrient mediums.

7. Results of technical testing are considered negative if the provided samples (sample) of medical product do not conform to requirements of standards, and also the declared technical characteristics of medical product which the producer uses for confirmation of conformity of medical product to General requirements.

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