Legal Framework

 

Since July 1, 2015, Ukraine has transitioned from a state registration system for medical devices to a conformity assessment system based on Technical Regulations. These regulations are derived from EU directives and include:

 

  • Technical Regulation on Medical Devices
  • Technical Regulation on In Vitro Diagnostic Medical Devices
  • Technical Regulation on Active Implantable Medical Devices

 

It is important to note that having a European CE certificate does not automatically grant access to the Ukrainian market. Manufacturers must undergo a national certification procedure.

 

 

Medical Device Classification

 

Medical devices are classified by risk level into the following categories:

 

  • Class I – Low risk
  • Class IIa – Medium risk
  • Class IIb – Increased risk
  • Class III – High risk

 

The device classification determines the required conformity assessment procedure and whether the involvement of a designated conformity assessment body is necessary.
 
 

Conformity Assessment Procedures

 

Depending on the class and characteristics of the medical device, different conformity assessment procedures apply:

 

  • Self-declaration and registration with the State Service of Ukraine on Medicines and Drugs Control: Applicable to Class I devices (non-sterile and without measuring functions). The manufacturer or authorized representative independently performs the required steps and issues a declaration of conformity.
  • Conformity assessment through manufacturing audit – Required for higher-risk devices. A designated conformity assessment body audits the manufacturer’s quality management system and reviews technical documentation.
  • Recognition of an EU certificate – Partial recognition of a CE certificate issued by an EU Notified Body is possible, which simplifies and speeds up the certification process in Ukraine.
  • Batch certification – Used for limited batches of devices. This procedure involves document review and sample testing (if necessary).

 

 

Key Stages of Certification

 

  • Appointment of an Authorized Representative – For non-resident manufacturers, it is mandatory to appoint an authorized representative in Ukraine responsible for placing the device on the market.
  • Development of Technical Documentation – Includes product descriptions, user instructions, test reports, risk assessments, and other required documents.
  • Implementation of a Quality Management System (QMS) – Higher-risk devices must comply with ISO 13485, ensuring quality control in production.
  • Conformity Assessment – Depending on the chosen procedure, this step may include manufacturing audits, technical documentation review, or other compliance checks.
  • Obtaining the Certificate of Conformity – Upon successful completion of the conformity assessment, a certificate is issued, confirming that the device meets Technical Regulation requirements.
  • Marking and Market Placement – The device is labeled with the national conformity mark and officially placed on the Ukrainian market.

 

 

Labeling Requirements

 

Medical device labeling must include the following information:

 

  • Device name and intended use
  • Manufacturer’s name and address
  • Authorized representative’s name and address in Ukraine
  • Batch number or serial number
  • Date of manufacture and/or expiration date
  • Storage and usage conditions
  • Compliance marking with technical regulations

 

All information must be provided in Ukrainian language.

 

 

Importance of Certification

 

Medical device certification ensures:

 

  • Patient safety – Guarantees that the device does not pose health risks.
  • Trust of medical professionals – Provides confidence in the reliability of the products they use.
  • Legal compliance – Prevents fines and sanctions for distributing non-certified products.

 

 

The certification process can be complex and resource-intensive. Seeking professional assistance can simplify procedures and ensure successful market entry for medical devices in Ukraine.