Difference in classification rules between national system in Russia and EAEU regulation
The system of national marketing authorization of medical devices in the Russian Federation uses the Nomenclature Classification of Medical Devices by Type (hereinafter referred to as “NCMD”). In the system of marketing authorization of Medical Devices in the EAEU, there is a very close equivalent in content: the European Medical Device Nomenclature (hereinafter referred to as “EMDN”).
According to EAEU regulatory documents, the EMDN must be harmonized with the Global Medical Device Nomenclature (hereinafter referred to as “GMDN”), at least in terms of the content (name, description) of the type codes of medical devices included in the GMDN. When it comes to its current form, the NCMD was also conceived as a system harmonized with the GMDN. Despite the apparent similarity of the approach, the NCMD and EMDN do not have to be equivalent.
Here are examples of such discrepancies:
|Type code (NCMD/EMDN)||Name (description) in the NCMD||Name (description) in the EMDN||Availability in the GMDN|
|331040||Intraoral optical scanning system
(An assembly of electronic devices intended to use optical technology to capture digital topographical 3D images of teeth, oral cavity structure and geometry, and the bite relationship of a patient; it is typically in addition capable of detecting dental caries. It consists of a hand-held intraoral scanner with near infrared (NIR) and laser illumination, and a mobile unit with a user interface with display/controls. The resulting digital dental impressions may be used for CAD/CAM fabrication of dental restorations and orthodontic devices.
|No such code||Yes (63669, Intraoral optical scanning system)|
|274570*||Monitoring system for multiple physiological parameters, clinical *
(An assembly of powered devices intended for use by a healthcare professional in a healthcare facility for intermittent or continuous assessment of several vital physiological parameters [e.g., electrocardiogram (ECG), non-invasive blood pressure (NIBP), pulse rate, temperature, haemoglobin oxygen saturation (SpO2)]. It consists of both physiological parameter sensors, probes and/or electrodes (e.g., ECG electrodes, blood pressure cuff) and data processing hardware with special software; it usually includes a screen for monitoring, but can be connected to a serial device for display)
* Previously, in the national registration system of the Russian Federation products belonging to the group “The System for Monitoring Physiological Parameters When Moving Patients” were registered under this type code
|The System for Monitoring Physiological Parameters When Moving Patients
(An assembly of battery powered devices for the continuous assessment of several vital physiological parameters [e.g., electrocardiogram (ECG), blood pressure, heart rate, temperature, cardiac output, apnoea, and respiratory/anaesthetic gases] of a patient during his/her transportation, for example, by ambulance during hospitalization or on a wheeled bed when transferred to another hospital department. The system typically contains a recorder, an amplifier, a display and leads/devices to be connected to the patient. It may also be used at the bedside where it is usually connected to the mains.)
|Yes (36872, Monitoring system for multiple physiological parameters, clinical)|
|190850||General-purpose multi-parameter bedside monitor
(An electrically powered device/an assembly of devices designed to continuously assess multiple vital physiological parameters (e.g., ECG, blood pressure, heart rate, temperature, cardiac output, apnoea, respiratory/anaesthetic gases) of an individual patient in intensive care or general care units. It is usually installed at the patient’s bedside and often includes programmable alarm devices, portable radio transmitters, receivers and antennae (for telemetry systems) for monitoring during patient movement or transportation; the system is not intended for neonatal patients and is not intended to be worn on the body.)
|System for monitoring physiological parameters of an individual patient
(An assembly of devices designed to continuously assess several vital physiological parameters (e.g., ECG, blood pressure, heart rate, temperature, cardiac output, apnoea, and respiratory/anaesthetic gases) of an individual patient. It typically includes a central station monitor that receives, aggregates and displays information, and a bedside monitor; it often contains portable radio transmitters, receivers and antennae (for telemetry systems) to monitor the outpatient; the system is not specifically designed for neonatal or ambulatory patients. It is used to assess and monitor trends in debilitated or unstable patients in intensive care and general care units.)
Yes (33586, General-purpose multi-parameter bedside monitor)