Understanding the intricacies of medical device certification can seem difficult even for those who have already encountered this topic many times. Therefore, we are sharing useful information and considering the main aspects and issues related to the certification of medical devices on the territory of Ukraine.

Let’s go! 

1. What is the certification process?

Certification of medical devices is a process of assessing the compliance of a medical device with the requirements of the Technical Regulations. Certification confirms the safety and effectiveness of medical devices used by humans.

2. Is national conformity assessment (certification) of medical devices mandatory?

Of course! Compliance assessment of medical devices is a legal requirement. This confirms the legal introduction of medical products into circulation on the territory of Ukraine and their subsequent sale.

3. Who is responsible for the medical device declaration procedure?

The responsibility for declaring the medical product lies directly with the manufacturer or an authorized person, in case the medical products are imported from other countries. The declaration is made under the full responsibility of the manufacturer.

4. What medical device certification procedures exist?

The procedure for evaluating the conformity of medical devices depends on the type and safety class of the medical device. The main procedures are self-declaration (for medical devices of the I-risk class, non-sterile, without a measurement function, for in vitro) and assessment of conformity through the manufacturer’s audit (I-sterile, with a measurement function, IIa, IIb, III).

In some cases, the batch certification or the procedure with EU recognition of the certificate is used.

5. What documents are required to issue a declaration of conformity of medical devices?

• list of products; 
• power of attorney to appoint an Authorized Representative (for a foreign manufacturer); 
• complete technical file for a medical product.

6. What organizations in Ukraine are involved in the certification of medical devices?

The centers of regulation and supervision are the Ministry of Economic Development and Trade, the Ministry of Health and the State Medical Service of Ukraine.

Assessment of the conformity of medical products in Ukraine is carried out by specially accredited conformity assessment organizations of state or private ownership. The current list of accredited organizations is published by the Ministry of Economic Development and Trade.

7. How does Miasphera help the manufacturer of medical devices?

Our experts accompany the manufacturer at all stages of the conformity assessment procedure, starting from consultation and collecting documents and ending with obtaining expert opinions. We also provide full legal support and Authorized Representative services.

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