Classification of medical products — Order 4n
MINISTRY OF HEALTH OF THE RUSSIAN FEDERATION, ORDER dated 06 June 2012 No. 4n “ON APPROVAL OF THE NOMENCLATURE CLASSIFICATION OF MEDICAL DEVICES” – review.
Appendix No. 1 to the Order on approval of the nomenclature classification of medical devices contains (please refer to Fig. 1) the numerical notation of the type of related medical device, i.e., a 6-digit unique identification entry code, the name of the medical device and a description of the related medical device.
The type name is not the standardised name of a specific medical device, but rather defines the type or typical group or class of devices with a similar or identical intended use and design (construction).
The description of the medical device type is based on 6 classification indices defining this type, namely, the scope of use, invasive/non-invasive nature, sterility, frequency of usage, specific design features, specific operational features; taken together, they allow the unambiguous classification of the medical device under the existing Nomenclature Classification. The Nomenclature classification of medical devices by type is presented in groups and sub-groups and published on the official Roszdravnadzor Web site http://www.roszdravnadzor.ru, under the “Electronic services” heading.
The name and/or description of the medical device may be changed from time to time, either due to increased detail requirements, or due to the emergence of totally new types of medical devices, resulting in the continuous need to update the Nomenclature Classification. That is why Roszdravnadzor updates the data presented in the Nomenclature Classification of medical devices at least once per month, and the related changes are posted on the official Roszdravnadzor Web site.
Appendix No. 2 to the Order on approval of the Nomenclature Classification contains a risk-based classification of medical devices. There are 4 main classes based on risk:
- Class 1: low risk medical devices
- Class 2a: moderate risk medical devices
- Class 2b: increased risk medical devices
- Class 3: high risk medical devices
This classification of medical devices considers their intended use and application conditions, as well as the following criteria:
- Length of application/usage,
- Invasive/non-invasive nature,
- Interaction with the human body,
- Power sources,
- Interaction with the vital functions of the human body.
It is important to consider that multi-class classification of medical devices is not allowed.
Let us highlight some specific features of medical device classification. So, when a medical device is intended for usage in conjunction with other medical devices, each of them has to be classified separately. However, if the medical device could be potentially classified under several classes, the class with the higher potential risk level has to be chosen as the final one.
When the standalone software (SW) is considered as a medical device, classification shall be performed as follows:
- When the SW concerned drives or affects the usage of a specific medical device, the SW has to be classified as per the intended use of the medical device driven (or affected).
- When the SW has no relation to the operation of any other medical device, it shall be classified individually according to the rules set forth in this Appendix.
For in vitro diagnostics medical devices, the following risk based classes are assumed:
- Class 1: medical devices of low individual and/or low public health risks,
- Class 2a: medical devices of moderate individual and/or low public health risks,
- Class 2b: medical devices of high individual and/or moderate public health risks,
- Class 3: medical devices of high individual and/or high public health risks.
Let us highlight some specific features of an in vitro diagnostics medical device classification based on the potential risk associated with its application.
- When the medical device is intended for usage in conjunction with other medical devices, each of them has to be classified separately.
- Calibrators and controls having qualitatively and quantitatively defined parameters shall have the same class as medical devices which use those calibrators and controls for QA purposes.
- When the software controls the operation or affects the results of the in vitro diagnostics medical device, it shall be classified under the same class as the medical device concerned for in vitro diagnostics.