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:
- Intended purpose — what condition, disease, or substance the IVD is designed to detect, monitor, or assess
- 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
| Class | Examples |
|---|---|
| Class I | General chemistry analysers, sample collection tubes with no diagnostic function |
| Class IIa | Pregnancy tests (such as HIV and hepatitis serology for blood donation purposes), with critical consequences of false results blood glucose monitors, urine dipsticks |
| Class IIb | HIV tests, hepatitis B/C tests, blood typing reagents |
| Class III | High-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.
GOST R 51088-2013 — gost.ru