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IVD Classification

Overview​

In Russia, IVD medical devices (in vitro diagnostics) are regulated as medical devices under the same Federal Law 323-FZ framework. They must be registered with Roszdravnadzor and are assigned to one of the four risk classes (I, IIa, IIb, III), aligned with the same risk-based principle applied to general medical devices.

Classification basis​

IVD classification is based on two main factors:

  1. Intended purpose — what condition, disease, or substance the IVD is designed to detect, monitor, or assess
  2. Risk to the patient — the potential consequences of a false positive or false negative result

High-risk IVDs — where an incorrect result could lead to life-threatening consequences — fall into Class IIb or Class III. Lower-risk IVDs used for general health monitoring may fall into Class I or IIa.

Examples by class​

ClassExamples
Class IGeneral chemistry analysers, sample collection tubes with no diagnostic function
Class IIaPregnancy tests, blood glucose monitors, urine dipsticks
Class IIbHIV tests, hepatitis B/C tests, blood typing reagents
Class IIIHigh-risk blood screening tests, tests for rare life-threatening infectious diseases

Applicable standards​

The key Russian standard for IVD devices is GOST R 51088-2013, which sets specific requirements for IVD registration dossiers. Performance evaluation data must demonstrate analytical and clinical performance.

Official source

GOST R 51088-2013 — gost.ru