Self-Declaration of Class I Medical Devices

 

Class I medical devices (non-sterile, without measuring functions) are the simplest from a regulatory oversight perspective. However, this doesn’t mean their introduction to the market doesn’t require proper legal preparation. One of the most common methods of legalizing such products on the Ukrainian market is self-declaration of conformity.
 
 

What is Self-Declaration?

 

Self-declaration is a procedure where the manufacturer independently confirms that the product meets the requirements of technical regulations without involving a conformity assessment body.
 
In Ukraine’s medical devices sector, self-declaration is allowed for:
 

  • Class I medical devices (excluding sterile or measuring function devices);
  • Custom-made devices;
  • Certain active implantable devices (in special cases only).

 

 

Regulatory Framework The primary documents regulating the medical device market in Ukraine are:

 

  • Technical Regulation on Medical Devices approved by the Cabinet of Ministers Resolution No.753;
  • Law of Ukraine “On Technical Regulations and Conformity Assessment”;
  • Cabinet of Ministers Resolution No.95 regarding recognition of foreign certificates.

 
 

What is required for self-declaration? The procedure includes the following steps:

 

  1. 1. Preparation of technical documentation;

 

  1. 2. Product labeling;

 

  1. 3. Implementation of a quality management system (recommended);

 

  1. 4. Maintaining a register of products placed on the market.

 

 

Are European Documents Recognized?

 

Cabinet of Ministers Resolution No.95 allows recognition of CE marking. However, this does not exempt manufacturers from formally conducting self-declaration under Ukrainian legislation.
 
 

Legal Risks Main risks:

 

  • Incorrect declaration of conformity;
  • Absence of Ukrainian labeling;
  • Incomplete technical documentation.

 

Possible consequences include product withdrawal and fines up to 170,000 UAH.
 
 

How ProPravo Can Help The ProPravo team:

 

  • Conducts document audits;
  • Prepares declarations of conformity;
  • Provides assistance during import procedures and regulatory inspections.