Declaration of Conformity

A Declaration of Conformity is a document issued by the manufacturer, guaranteeing that the product meets the requirements established by legislation.

This definition is derived from the Law of Ukraine on Technical Regulations and Conformity Assessment.

The Declaration of Conformity for medical devices is an official document issued by the manufacturer that confirms the medical device’s compliance with the requirements of technical regulations and safety standards. This document is typically issued based on the results of tests and conformity assessments of the product to the established requirements.

The Declaration is required for placing a medical device on the market in Ukraine, as well as for exporting the device outside the country. It is one of the key documents indicating the safety and quality of the product and is a crucial part of the medical device certification process.