Technical Regulation No. 754

Technical Regulation No. 754 – is a resolution approved by the Cabinet of Ministers of Ukraine on October 2, 2013, concerning the regulation of in vitro diagnostic medical devices. The Technical Regulation sets requirements for in vitro diagnostic medical devices that must be met before they can be placed on the market. The document consists of the main part and 9 Appendices. This Technical Regulation was developed based on the European Parliament and Council Directive 98/79/EC of October 27, 1998, on in vitro diagnostic medical devices.

According to Technical Regulation No. 754, an in vitro medical device is a medical device, including reagents, calibrators, control materials, kits, instruments, apparatus, equipment, or systems, used either individually or in combination, intended by the manufacturer for in vitro use to examine samples, including blood and tissue samples taken from the human body solely (or primarily) for obtaining information:

• Regarding physiological or pathological conditions;
• Regarding congenital anomalies;
• To determine safety and compatibility with potential recipients;
• For monitoring therapeutic measures.

To place an in vitro medical device on the market, it must undergo a conformity assessment by a conformity assessment body or be registered with the State Drug Administration. In addition to certification/registration, technical documentation must be prepared and maintained, which should include:

• A general description of the device, its modifications, construction, component diagrams, and manufacturing methods;
• A list of applicable standards;
• Results of preclinical studies: data on the evaluation of characteristics demonstrating the properties claimed by the manufacturer, accompanied by a measurement reference system (if available) with information on reference methods, reference materials (standard samples), known reference values, accuracy parameters, and units of measurement used (such data should come from studies conducted in clinical or other relevant conditions, or be based on relevant bibliographic references);
• Results of risk analysis;
• Labels and instructions for use;
• Results of stability studies.

For all in vitro medical devices, it is crucial to focus on confirming the accuracy of measurements and the effectiveness of the device’s application, as this is considered during the conformity assessment by the conformity assessment body and during market surveillance by the State Drug Administration.