Self-declaration

The procedure of self-declaration to technical regulations is used for:

  • Class I medical devices are not sterile, without a measuring function;
  • Medical products for in vitro diagnostics, which are not included in lists "A" and "B" of Technical Regulation No. 754, and are not products for self-monitoring.

To complete the self-declaration procedure, you must:

  • Obtain Power of Attorney as an authorized representative of the manufacturer in Ukraine.
  • Create a Technical File in accordance with the requirements of the Technical Regulations.
Requirements:
  1. A general description of the medical device, including any planned modifications to such a device, as well as its intended use;
  2. Design drawings, information on the intended methods of manufacturing the specified medical product, as well as diagrams of components, nodes, circuits, etc.;
  3. Description and explanation necessary for understanding the specified drawings, diagrams and operation of the medical product;
  4. The results of the risk analysis, information on the standards that are applied in whole or in part, from among those which are included in the list of standards that correspond to European harmonized standards and are voluntary the use of which can be perceived as proof of compliance of medical devices with the requirements of the Technical Regulation on medical devices, as well as a description of the decisions made in order to fulfill the requirements of the Technical Regulation on medical devices in case of partial application of the specified standards;
  5. Results of design calculations and inspections. If the medical product is intended to be connected to other medical devices for the purpose of use as intended, confirmation of compliance with the requirements is provided Technical regulations on medical devices, provided they are connected to other medical devices;
  6. Results of preclinical evaluation;
  7. Clinical evaluation results;
  8. Label and instructions for use.

The authorized representative must:

  • Translate the manufacturer's documentation into Ukrainian;
  • Make a Declaration of compliance with the requirements of the Technical Regulations;
  • Get the technical file from the manufacturer;
  • Develop product labeling that would meet the requirements of the Technical Regulations and normative documents;
  • Enter the specified products into the register of the State Service of Medicinal Products and Drug Control.
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