Service conformity assessment

LLC Ukrainian Certification Agency LLC is an authorized body for assessing the conformity of products with the requirements of the Technical Regulations for medical devices and in vitro products.

The decision to appoint a conformity assessment body to conduct conformity assessment with the requirements of the relevant technical regulation is an order of the Ministry of Economy of February 24, 2017 No. 265.

The decision to appoint a conformity assessment body to conduct conformity assessment of the requirements of the Technical Regulations for in vitro diagnostic medical devices, approved by the Cabinet of Ministers of Ukraine dated October 2, 2013 No. 754 - order of the Ministry of Economy of October 3, 2019 No. 159.

The identification number of the authority is UA.TR.121.

From July 1, 2015, a mandatory requirement for the introduction and circulation or operation of medical devices on the Ukrainian market was the assessment of compliance with the requirements of technical regulations approved by resolutions of the Cabinet of Ministers of Ukraine dated 02.10.2013 No. 753, No. 754, No. 755.

On July 1, 2017, the transition period from the state registration of medical devices to the conformity assessment procedure ended, as a result - since July 2, 2017, legalization of medical devices in Ukraine takes place exclusively through the conformity assessment procedure with technical regulations.

Starting July 2, 2017, medical devices (except for custom-made or intended for clinical research) must be marked with a national conformity mark before being put into circulation. Markings must be clearly visible, legible and must not be erased. Along with the national conformity mark, the identification number of the conformity assessment body responsible for carrying out the procedures is indicated.

Depending on the classification of the medical device, a way is chosen to confirm the compliance of the device with the requirements of the relevant technical regulation. When choosing a way to conduct conformity assessment, it is necessary to be guided by conformity assessment procedures in accordance with the Technical Regulations for medical devices.

Representatives of Ukrainian Certification Agency LLC will help to fill out an application and choose the right conformity assessment procedure, as well as to understand all aspects of the legislation on the implementation of the relevant work.

If a signed application is submitted to the conformity assessment body, the applicant cannot submit a similar application to another conformity assessment body.

For more detailed information, we suggest that you go to the "contacts" page and contact us in a convenient way for you.

Drawing a national mark of conformity on products

According to the technical regulations for medical devices, for medical devices for in vitro diagnostics, for active medical devices that are implanted, approved by resolutions of the Cabinet of Ministers of Ukraine of October 2, 2013 No. 753, No. 754, No. 755, it was established that, after carrying out the necessary procedures, the introduction of medical devices into circulation, it is necessary to mark with a mark of compliance with technical regulations on medical devices for all risk classes (except for custom-made or intended for clinical trials).

Marking with a mark of compliance with technical regulations is applied by decision of the manufacturer to the medical device or its packaging, as well as to instructions for use of the medical device, if such an instruction is mandatory. Marking should be clearly visible, legible and should not be erased. Marking with a mark of compliance with technical regulations can be applied to the label of a medical device.

Next to the mark of compliance with technical regulations, the identification number of the conformity assessment body responsible for carrying out the procedures is indicated (if any), as shown below:

The mark of conformity with technical regulations is applied in accordance with the form, description of the mark of conformity with technical regulations, the rules and conditions for its application, approved by the Cabinet of Ministers of Ukraine dated December 30, 2015 No. 1184.

The mark of conformity to technical regulations (hereinafter referred to as the mark of conformity) has the form of a circle not open on the right side, inside which a stylized image of a trefoil is placed. The length of the gap circle is 0.22 of its total length (or 80 degrees).

The image of the conformity mark can be flat or embossed and is performed in two contrasting colors.

The height of the conformity mark may not be less than 5 millimeters, unless otherwise provided by the relevant technical regulation.

If the sign decreases or increases, the appropriate proportions must be observed.

The size of the mark of compliance with technical regulations may not be less than 5 millimeters. The indicated minimum size can be reduced for small items.

The mark of compliance with technical regulations is applied to the product or to its plate with technical data in such a way that it is visible, legible and indelible. In the case when this is not possible due to the nature of the product, the mark of conformity is applied to the packaging and accompanying documents, if such documents are provided for by the relevant technical regulations.

In accordance with Articles 8 and 11 of the Law of Ukraine “On Technical Regulations and Conformity Assessment”, the List of areas of activity in which the central executive authorities carry out the functions of technical regulation approved by the Cabinet of Ministers of Ukraine dated December 16, 2015 No. 1057, and In order to improve technical regulation in the field of circulation of medical devices, medical products for in vitro diagnostics, active medical devices that are implanted, the Ministry of Health No. 1242, No. 1243, and No. 1245 of October 10, 2017 approved lists of national standards, the compliance of which provides a presumption of compliance medical devices to the requirements of the Technical Regulations approved by resolutions of the Cabinet of Ministers of Ukraine of October 2, 2013 No. 753, No. 754, No. 755