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Regarding the position of the Ministry of Economy of Ukraine as the main technical regulator in the system of central executive bodies on the legality and legality of conformity assessment of medical devices to the requirements of relevant technical regulations by recognizing the results of conformity assessment

The Ministry of Economy of Ukraine in its letter № 3432-06 / 28337-07 dated 04.05.2020 noted that parts two and three of Article 45 of the Law of Ukraine “On Technical Regulations and Conformity Assessment” (hereinafter – the Law) define two equivalent ways of recognition and acceptance in Ukraine on the results of conformity assessment work carried out in other states – on the basis of an international agreement between Ukraine and a certain state, which provides for mutual recognition of conformity assessment results, or on the basis of an agreement on recognition of conformity assessment results between Ukrainian designated conformity assessment bodies and foreign accredited conformity assessment bodies.

The Ministry of Economy of Ukraine considers that the Ukrainian designated conformity assessment body performs the conformity assessment procedure defined in the technical regulations for medical devices, which recognizes certain conformity assessment works of the above European Union directives carried out by a European notified body on the basis of a contract ( agreements) on recognition with such a body, ensure compliance with the Ukrainian designated body for assessing compliance with the provisions of the first part of Article 45 of the Law in view of the following.

Part one of Article 45 of the Law establishes the general principle of recognition of conformity assessment results performed outside Ukraine, which applies to both methods of recognition – the results of conformity assessment conducted in another state are recognized and accepted in Ukraine if conformity assessment procedures are applied in that state ( even if they differ from Ukrainian procedures) provide the same or higher level of compliance with the requirements of the relevant technical regulations as Ukrainian conformity assessment procedures.

Part three of Article 45 of the Law does not contain requirements for the conclusion by Ukrainian designated conformity assessment bodies with foreign accredited conformity assessment bodies only of agreements on mutual recognition of conformity assessment results.

Given the content of this part, the Ukrainian designated conformity assessment body must first examine whether the conformity assessment procedures applied in another country (even if they differ from Ukrainian procedures) ensure not the lowest level of compliance with the relevant technical regulations as well as Ukrainian conformity assessment procedures. .

If the results of the study are positive, the Ukrainian designated conformity assessment body should obtain information from the foreign conformity assessment body on its accreditation in the relevant field and verify that the national accreditation body that has accredited such a foreign conformity assessment body is a member of the international conformity assessment body. or a regional accreditation body and / or has entered into a mutual recognition agreement with such organization in relation to the relevant conformity assessment activities.

In addition, in accordance with the third paragraph of the third part of Article 45 of the Law, the conformity assessment body (test reports, conformity documents, etc.) conducted by a foreign accredited conformity assessment body is appointed, applies the conformity assessment procedure or part thereof and issues a document about the conformity provided by this procedure, under the responsibility.

Thus, the Ministry of Economy of Ukraine considers that subject to the above requirements, the Ukrainian designated conformity assessment body has the right to enter into an agreement (agreement) with a foreign accredited conformity assessment body on recognition (both mutual and unilateral) of the results of conformity assessment and within the framework of such an agreement (contract) on the basis of a document of conformity issued by a foreign accredited conformity assessment body, apply the conformity assessment procedure or its part and issue the document of conformity provided by this procedure under its responsibility.

As for the terms of such agreements (contracts), according to the letter of the Ministry, they are determined by agreement of the parties.

At the same time, the chief technical regulator notes that the current legislation does not define a standard or approximate form of agreements on recognition of conformity assessment results between conformity assessment bodies, which, in turn, allows conformity assessment bodies to use their own developed forms.

In the opinion of the Ministry of Economy of Ukraine, the conformity assessment procedures provided for in Directives № 93/42 / EEC, № 98/79 / EEC and № 90/385 / EEC ensure the same level of compliance, respectively.

– Technical regulations on medical devices, approved by the resolution of the Cabinet of Ministers of Ukraine dated 02.10.2013 № 753,

– Technical regulations on medical devices for in vitro diagnostics, approved by the resolution of the Cabinet of Ministers of Ukraine dated 02.10.2013 № 754,

– Technical regulations on active implantable medical devices, approved by the resolution of the Cabinet of Ministers of Ukraine dated 02.10.2013 № 755,

as well as the Ukrainian conformity assessment procedures provided for in these technical regulations.

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