Self-declaration (class I and IVD’s)

Safest medical devices can follow the simplified conformity assessment procedure in Ukraine that is also known as “self-declaration”. 

The procedure applies only to the following classes of medical devices:

• Class I medical devices, not sterile and without measuring functions;
• Medical devices for in vitro diagnostics (analyzers, reagents, calibrators, controls, etc.) that are not included in the Lists “A” and “B” and are not intended for self-testing.

The Manufacturer and/or its Authorized Representative ensures and declares that the medical devices meet the provisions of the relevant Technical regulation which apply to them by preparing the technical documentation (that should include Ukrainian documents and forms), issues the UA Declaration of conformity, and submits the documents for registration to the competent authority State Service of Ukraine on Medicines and Drugs Control (“SMDC”). The procedure of internal control puts the responsibility of conformity assessment on the manufacturer and/or its Authorized representative. 

This procedure is established by Annex VIII to the Technical regulations on medical devices and by Annex III to the Technical regulations on medical devices for in-vitro diagnostics. Essential requirements for medical devices are defined in Annex I to each Technical regulation. The procedure of registration at the competent authority is approved by Order No. 122 of the Ministry of Health of Ukraine dated February 10, 2017.  

Correct “self-declaration” procedure: 

1. Non-resident Manufacturer designates Authorized representative in Ukraine by issuing a properly executed document. An Authorized representative is responsible for placing of the medical devices on the market. The national Manufacturer need no Authorized representative. 

2. The Manufacturer or the Authorized representative should prepare / collect the technical documents as specified in the Annex to the Technical regulations (Annex VIII to TR 753 on medical devices / Annex III to TR 7534 on medical devices for in-vitro diagnostics). Based on this documentation, “internal quality control”, i.e. check of compliance with the requirements specified in Appendix I to the Technical regulations, should be carried out. 

After that, the Technical documents must be kept for five years from the date of the introduction of the last medical device into circulation in Ukraine. This documentation should be provided upon request by market surveillance authorities (State Service of Ukraine on Medicines and Drugs Control, State Consumer Service) during scheduled and unscheduled inspections.

The list of the documents for medical devices (Appendix VIII to TR 753): 

• Description of the medical device and its modifications, information on the intended use;
• Draft drawings, data on the manufacture of medical device, components, assemblies, etc.;
• Results of risk analysis; 
• Evidence of conformity to the requirements of the Technical Regulations:
  • If standards are used: List of harmonized standards from the list approved by the Ministry of Health of Ukraine; 
  • If standards are not used:Description of the decisions taken to fulfill the requirements of the regulations;

• Protocols of the testing for compliance with the standards, results of design calculations and tests; 
• Decisions made during the development and design of medical devices aimed at eliminating or reducing risks (safe design and construction), taking measures to protect consumers, informing users on potential risks; 
• Evidence of compatibility and characteristics preservation, if the device should be connected to another device; 
• Results of nonclinical evaluation;
• Results of clinical evaluation;
• Labeling and IFU; 

List of documents for medical devices for in vitro diagnostics (Appendix III to TR 754): 

• General description of the product, including any scheduled modifications;
• Documents on the quality management system;
• Information on the product design, characteristics of basic materials, characteristics and limitations of product use, manufacturing methods, as well as, if appropriate, information on designs of components, assemblies, circuits, etc.;
• Information on the origin of human tissues or substances derived from the human tissue and conditions of their collection (if applicable); 
• Descriptions and explanations required for the understanding of drawings, diagrams and the operation of the product;
• Results of risk analysis; 
• Evidence of conformity to the requirements of the Technical Regulations:
  • If standards are used: List of harmonized standards from the list approved by the Ministry of Health of Ukraine; 
  • If standards are not used:Description of the decisions taken to fulfill the requirements of the regulations;
• Descriptions of the procedures used for sterile products, products in special microbiological conditions or other purity conditions;
• Results of the design calculations and tests;
• Evidence of conformity and characteristics preservation when the device should be connected to another device (if provided); 
• Testing reports;
• Data on performance assessment that demonstrate the properties declared by the manufacturer, accompanied by a reference measurement system (if available) with the information on reference methods, reference materials (standard samples), known reference values, accuracy parameters and units of measurement used (based on clinical and other studies, bibliographic materials); 
• Labeling and IFU; 
• Results of stability studies.

Foreign manufacturer provides these data to its Authorized representative which is obliged to keep it for five years. National manufacturer develops and conducts testing and studies, stores these documents on its own.

3. If required, part of the documents should be translated into Ukrainian. 

4. Labeling and IFU should be prepared and must comply with the requirements of the Technical Regulations, the Laws “On Ensuring the Functioning of the Ukrainian Language as the State Language”, “On the Protection of Consumer Rights” and other legislative acts. 

5. The Essential requirements “checklist” (Annex I) is the main evidence of conformity of the medical device to the requirements of the Technical regulations. Checklist should be filled in Ukrainian language and kept with other technical documents as demonstration of conformity.  

The checklist is filled in on the basis of the documents described in clause 2 above. The checklist is usually filled in as a table with the list of decisions and evidence of conformity (standards, protocols, documents, etc.) provided for each requirement of the Technical regulation. 

The checklist is one of the main documents that are requested during inspections. 

6. After the internal control of the Essential Requirements, the Manufacturer or its Authorized representative can sign the Declaration of Conformity. 

By signing the Declaration, the Manufacturer or its Authorized Representative declares and guarantees that they have carried out all the necessary actions, checked and proved that the medical device meets the requirements of the Technical Regulations. By signing the declaration, the Manufacturer or its Authorized Representative confirms that all requirements for the medical device efficacy and safety have been verified and are met, and supporting evidences have been collected. 

The Declaration of Conformity is drawn up in free format, but there are a lot of peculiarities concerning its correct execution for trouble-free import, sale, participation in tenders, etc. 

After the issuance of the Declaration of Conformity, the Manufacturer or its Authorized representative has the right to affix the symbol (mark) of conformity with technical regulations on the labeling. 

7. Notification with a set of documents should be submitted to the State Service of Ukraine on Medicines and Drugs Control for registration of the person responsible for placing of the medical device on the market. The State Service of Ukraine on Medicines and Drugs Control reviews the documents within 10 business days and, if they are duly executed, enters the information into the register. 

It is important to understand that the State Service of Ukraine on Medicines and Drugs Control does not check the product class and does not conduct an expert examination of the documents prior to entering the information into the Register, but only checks formal signs, trusting and leaving the responsibility to the Authorized representative and the manufacturer. 

8. After entering the information into the register, the Manufacturer or its Authorized representative has the right to import the medical devices and place them on the market of Ukraine. 

Most frequently asked questions 

Question: If the State Service of Ukraine on Medicines and Drugs Control has completed registration, does this mean that the class of the product and the correctness of the “self-declaration” have been confirmed? 
Answer: No, the State Service of Ukraine on Medicines and Drugs Control checks only formal signs and enters the data into the Register. Completeness and correctness of the documents are the responsibility of the Manufacturer and its Authorized representative. 

Question: Is the application to the designated authority required to carry out a “self-declaration” procedure?
Answer: No, it is not required. The letter confirming the product class is voluntary. All actions before submission to the State Service of Ukraine on Medicines and Drugs Control can be carried out by the Manufacturer or its Authorized Representative on their own. 

Question: What is the responsibility if the Declaration is just signed and registration is carried out, without preparing and processing the rest of the documents? 
Answer: Market surveillance authorities carry out scheduled and unscheduled inspections of retail, storage and manufacturing sites of medical devices. The Manufacturer or the Authorized representative of the non-resident manufacturer is obliged to provide the technical documentation for the medical device and all other information confirming that the requirements of the technical regulation are met. According to article 44 of the Law of Ukraine “On State Market Surveillance and Control of Non-Food Products”, the minimum fine for putting into circulation the products that do not meet the requirements of technical regulations is UAH 51,000. In addition, the market surveillance authority can issue a decision to suspend or prohibit the circulation of the products. There are also risks of additional VAT charges of up to 20 % and other fines.