The Declaration of Conformity is a document in which the manufacturer confirms that a product meets requirements of the relevant regulatory acts (technical regulations).
In cases specified in the Technical Regulations, the Manufacturer or his Authorized Representative (on behalf of and under the responsibility of the Manufacturer) is obliged to draw up a Declaration of Conformity.
The Declaration of Conformity is drawn up in accordance with requirements and the approximate structure of the relevant Technical Regulation. However, as far as Technical Regulations governing the sphere of medical devices (Technical Regulations on Medical Devices, Technical Regulations on Medical Devices for in vitro Diagnostics, Technical Regulations on Active Implantable Medical Devices, as approved by Resolutions of the Cabinet of Ministers No. 753, 754, 755 dated 02/10/2013), neither establish nor determine the approximate form of the Declaration of Conformity (compared to other Technical Regulations).
Such lack of proper regulation as to what information should be contained in the Declaration of Conformity for medical devices and what data should be displayed in this document leads in practice to the fact that importers and distributors have some difficulties with confirming compliance with regulatory requirements and passing conformity assessment procedures for imported products during customs clearance.
Such difficulties can be eliminated by correct execution of a Declaration of Conformity for medical devices.
It is also important to note that some medical devices are subject to several Technical Regulations at the same time, each of them specifying requirements to execution of a Declaration of Conformity.
In such cases, a single Declaration of Conformity should be drawn up with respect to all such Technical Regulations, if provided by the relevant Technical Regulations.
The single Declaration of Conformity may take the form of a dossier consisting of respective separate declarations.
Taking into account that the Declaration of Conformity for medical devices is the main document for importation of products into Ukraine (along with a Certificate of Conformity), it is very important to draw up a document correctly, to know the procedure of amending it and any other important issues.
For all questions regarding the regulation of the sphere of medical devices, you may always contact us by phone +38044 360 30 11
Our experts will advise and assist in preparation of any necessary documents.