Conformity assessment of medical devices
Assessment of Conformity of Medical Devices – This is a process carried out by the manufacturer or a designated body to demonstrate that the specified requirements related to medical devices have been met. These requirements refer to the Technical Regulations on Medical Devices No. 753, No. 754 on In Vitro Medical Devices, and No. 755 on Active Implantable Medical Devices. The process of conformity assessment is often understood as the registration of medical devices.
Depending on the risk class of the medical device, the conformity assessment procedures may differ. For example, a dental unit of class IIa will require mandatory certification by a conformity assessment body, while reusable dental instruments of class I will only need to be registered with the State Drug Administration.
The procedures for conformity assessment according to the risk class are shown in Table 1:
| Class of Medical Device | Conformity Assessment Procedure |
| Technical Regulation No. 753 | |
| I | Registration in the State Drug Administration Register |
| Is | Conformity assessment by a conformity assessment body |
| IIa | Conformity assessment by a conformity assessment body |
| IIb | Conformity assessment by a conformity assessment body |
| III | Conformity assessment by a conformity assessment body + design examination by the conformity assessment body |
| Technical Regulation No. 754 | |
| In vitro List A | Conformity assessment by a conformity assessment body |
| In vitro List B | Conformity assessment by a conformity assessment body |
| In vitro for self-testing | Conformity assessment by a conformity assessment body |
| Other in vitro medical devices (not List A, not List B, not for self-testing) | Registration in the State Drug Administration Register |
To successfully conduct the conformity assessment of medical devices, technical documentation must be prepared and submitted to the body along with the application for conformity assessment. The technical documentation includes:
- Description of the device with all modifications, drawings, and images
- List of applicable standards
- Results of preclinical tests (biocompatibility, electrical safety, validation, etc.)
- Risk analysis results
- Results of clinical evaluation or clinical trials
- Declaration of conformity with the technical regulation
- Labeling and instructions for use
When preparing documentation for a foreign manufacturer, attention must be paid to labeling and instructions in Ukrainian. This is a mandatory requirement under the Technical Regulation and the Law of Ukraine “On the Functioning of the Ukrainian Language as the State Language.”
If medical devices fall under mandatory registration with the State Drug Administration, technical documentation is not required during registration. It is sufficient to prepare a declaration of conformity, a letter confirming the class from the conformity assessment body, and enter the necessary information in the Service Recipient Cabinet: https://citizen-portal-drmv-main.apps.krrt.ncr.gov.ua/login
It is important to note that although technical documentation is not required during registration, it must be available to all manufacturers or their authorized representatives in Ukraine and presented to the market surveillance experts of the State Drug Administration during market surveillance.