TR 753

The abbreviated name of the Technical Regulations on Medical Devices approved by the Cabinet of Ministers of Ukraine on October 2, 2013, No. 753.

The Technical Regulations establish the requirements for medical devices that must be met before they are placed on the market. The document consists of a main part and 10 Appendices.

The Technical Regulations on Medical Devices were developed based on the EU Council Directive of June 14, 1993, No. 93/42/EEC concerning medical devices. The text of the regulation is almost identical to the aforementioned EU Directive.

The regulation is part of the system of technical regulation for non-food products in Ukraine.