Risk Management (GOST R ISO 14971)
The applicable standard
Russia requires risk management to be conducted in accordance with GOST R ISO 14971 — the Russian adoption of the international standard ISO 14971 "Medical devices — Application of risk management to medical devices."
The standard is adopted verbatim from ISO 14971 and covers the same requirements. A risk management file that complies with ISO 14971 will generally satisfy GOST R ISO 14971 requirements.
What the risk management file must contain
The risk management file submitted as part of the registration dossier must demonstrate:
- Hazard identification — all foreseeable hazards associated with the device and its intended use have been identified
- Risk estimation — probability and severity of harm assessed for each hazard
- Risk evaluation — determination of whether each risk meets acceptability criteria
- Risk control measures — design controls, protective measures, and information for safety implemented
- Residual risk evaluation — residual risks after control measures are acceptable
- Overall residual risk — benefit-risk assessment is positive
- Post-market data — a mechanism exists to review risk management findings with post-market data
Integration with registration
The risk management file is a mandatory component of the registration dossier for all device classes. The FGBU expert institution reviews the risk management file as part of the dossier assessment and may request additional information where risks are not adequately addressed.
EAEU requirements
The EAEU pathway also requires a risk management file aligned with ISO 14971 (GOST R ISO 14971). Requirements are the same in substance.
GOST R ISO 14971: gost.ru