Regulation medical devices

In Ukraine, the Technical Regulation on Medical Devices (TR 753) and its related auxiliary aids include requirements for the development (if applicable), manufacturing, and final inspection of medical devices (both non-active and active devices that are not intended for implantation).

In Europe, the Medical Devices Regulation (MDR) is the European legislative act that governs medical devices sold within the European Union. This regulation replaced the previous legislative act governing medical devices in Europe the Medical Devices Directive 93/42/EEC.

The conformity assessment of medical devices under the MDR involves a detailed analysis of the technical documentation provided by the manufacturer, conducting tests, and evaluating whether the results meet MDR requirements.

Key requirements of the MDR include:

– Safety and effectiveness of medical devices
– Labeling and identification procedures
– Requirements for clinical trials and post-market surveillance
– Organization and maintenance of manufacturer documentation
– Various other requirements

Conformity assessment under the MDR ensures the safety and effectiveness of medical devices sold in the European Union. It also maintains consistent quality standards for medical devices across different European countries and enhances the trust of patients and healthcare professionals in medical devices.