Self-declaration for low-risk medical devices
Ensure compliance of your products with Ukrainian regulations easily and quickly!
Who is this procedure for?
The self-declaration procedure is mandatory for low-risk medical devices, including:
-
Class I
non-sterile, without measurement function
-
Medical devices for in vitro diagnostics
analyzers, reagents, calibrators that are not included in the list “A” or “B” and are not intended for self-monitoring
Main stages of self-declaration
-
Appointment of an authorized representative
The manufacturer appoints an authorized representative in Ukraine who is responsible for the conformity assessment process, as well as for signing and submitting the declaration of conformity on behalf of the manufacturer
-
Preparation of technical documentation
Technical documentation must be prepared in accordance with Annex 8 of the Technical Regulations (for medical devices) or Annex 3 (for in vitro diagnostic products). The documentation must be up-to-date and kept for the entire period of validity of the declaration of conformity.
-
Translation of instructions and labeling
Instructions for use of the product and labeling must be translated into Ukrainian
-
Completion of the checklist
In accordance with Annex 1 of the Technical Regulation, a checklist of the main requirements for a particular product is filled in
-
Preparation of a declaration of conformity
The manufacturer or an authorized representative prepares a declaration of conformity, which confirms that the product meets the basic requirements of the Technical Regulations
-
Electronic notification to the State Service of Ukraine on Medicines and Drugs Control (SMDC)
Upon completion of the preparation of documents, they are submitted to the State Service of Ukraine on Medicines and Drugs Control (SMDC) through an electronic system. The procedure also includes submission of documents for registration in the State Register of Medical Devices.