Information services

The Ukrainian Scientific Institute of Certification provides information services exclusively within its competence related to medical devices, personal protective equipment and certification of quality management systems. Thanks to the experience of cooperation with the largest suppliers and manufacturers on the Ukrainian market, concluded agreements on the recognition of the conformity assessment results with leading European notified bodies, UNI-CERT specialists are among the most qualified in this industry and can answer almost all questions that arise. They are versed in national and international legislation in the field of technical regulation at a high level, including in its original language.

The main list of provided information services is as follows:

  • Confirmation of product compliance with the definition of a medical device, in vitro diagnostic medical device, accessory, personal protective equipment, based on its intended use and indications for use, as well as confirmation of the correct classification of such products by the manufacturer, in accordance with the definitions set out in:
  1. Technical regulations on medical devices, approved by the Resolution of the Cabinet of Ministers of Ukraine No. 753 dated 02.10.2013
  2. Technical regulations on in vitro diagnostic medical devices, approved by the Resolution of the Cabinet of Ministers of Ukraine No. 754 dated 02.10.2013
  3. Technical regulations on personal protective equipment, approved by the Resolution of the Cabinet of Ministers of Ukraine No. 761 of August 27, 2008
  • Clarifications for government agencies, tender committees, etc.

The usual term for the provision of the service is from one to three working days after the submission of all the necessary documents and payment.

We will be happy to answer your questions, you can contact us on the contact page.

Other services

Conformity assessment of medical devices

Since 1 July 2015, it has been a mandatory requirement that medical devices, before being placed on the Ukrainian market and/or put into service, must be subject to the assessment of conformity with the Technical regulations (TR) (approved by Resolutions No. 753, 754, 755 of the CMU of 2 October 2013). Clause 21 of Resolution No. […]

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Testing of the product characteristics

The National Accreditation Agency of Ukraine confirmed the technical competence of the UNI-CERT Testing Laboratory against DSTU ISO/IEC 17025:2017 General Requirements for the Competence of Testing and Calibration Laboratories (ISO/IEC 17025:2017, IDT) with an Accreditation certificate No. 201394 dated 20 April 2021). The laboratory’s scope of activities covers the testing of the following products: medical devices, namely […]

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Conformity assessment of personal protective equipment

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