Technical Regulation No. 755
Technical Regulation No. 755 – This is a resolution approved by the Cabinet of Ministers of Ukraine on October 2, 2013, concerning active implantable medical devices. The Technical Regulation sets the requirements for active implantable medical devices that must be met before they can be marketed. This Technical Regulation is based on the Council Directive of the European Union of June 20, 1990, No. 90/385/EEC concerning the approximation of the laws of the Member States relating to active implantable medical devices. This Technical Regulation applies to devices that, in addition to containing a power source as an integral part, are implanted into the human body. Such medical devices are classified as high-risk to patient health and require the involvement of a conformity assessment body regardless of their function.
Along with the application to the conformity assessment body, the following must be submitted:
- Manufacturer’s quality objectives.
- Organizational structure of the enterprise.
- List of applicable standards and test results (preclinical testing).
- Results of preclinical evaluation of the device.
- Methods for checking and ensuring quality during the production phase, including:
- Processes and procedures to be used, including during sterilization and procurement.
- Procedures for identifying products at each stage of production based on drawings, specifications, or other appropriate documents.
- List of relevant tests and studies to be conducted before, during, and after the production of the devices, their frequency, and the testing equipment to be used.
Examples of active implantable medical devices include pacemakers, neurostimulators, insulin pumps, brain stimulation systems, drug infusion systems, and others.