FOR LOW-RISK MI MANUFACTURERS, THE IMPLEMENTATION OF A QUALITY MANAGEMENT SYSTEM WILL BE VOLUNTARY

The Ministry of Health of the Russian Federation presented a draft requirements for the implementation, maintenance and assessment of a quality management system for medical devices, depending on the potential risk of their use. The introduction of the system will be voluntary for manufacturers of medical devices of the first and non-sterile medical devices of risk class 2a, for the rest it will be mandatory.

As follows from the draft document, manufacturers of medical devices will be obliged to implement a quality management system for medical devices depending on the class of potential risk of their use, and enterprises producing medical devices of the 1st class and non-sterile medical devices of the 2nd class will be able to do this on a voluntary basis. For companies producing medical devices of class 2a and 2b, the quality management system will not be mandatory in relation to the design and development of medical devices.

To implement the system, the manufacturer will be obliged to develop requirements for risk management at all stages of the life cycle of medical devices, as well as parameters for their implementation into practice and implementation at the enterprise, including the sequence and interconnection of these processes. In addition, the manufacturer will be required to define criteria and methods for assessing the effectiveness of the management system, monitor, measure and analyze processes, and take actions necessary to achieve planned results.

Evaluation of the effectiveness of the quality management system will be carried out according to the design and development processes, if they are included in the quality management system of the manufacturer of the medical device, document and record management, production and final control, corrective and preventive actions, and consumer-related processes.

In particular, manufacturers will be obliged to maintain feedback with the consumer throughout the entire life cycle of using a medical device and, if necessary, make adjustments to the development and production of medical devices to eliminate the identified deficiencies.