
Medical device risk management file
Manufacturers of medical devices should implement a risk management process throughout the life cycle of the medical device.
The purpose of the risk management process is to reduce the risk of a medical device to an acceptable level. This means that the benefits from the use of the medical device must exceed the residual risks.
The process of medical device risk management must be implemented in accordance with the requirements of GOST ISO 14971-2021 ‘Medical devices. Application of risk management to medical devices’.
The risk management process should begin with a risk analysis, including:
- determination of characteristics related to the safety of the medical device.
- identification of dangers;
- compilation of a list of dangers. Then, for each danger situation, the potential harm should be determined.
Based on the results of the assessment of probability and severity for each harm, a list of risks of the medical device should be formed, which are further evaluated in terms of their acceptability or unacceptability.
The manufacturer himself develops the form and requirements for the risk management file, based on the requirements of GOST ISO 14971-2021.
The notice from the manufacturer's risk management file is part of the technical documentation to be submitted to Roszdravnadzor and must include: identification of all risks, both under normal operating conditions and under conditions of refusal, risk assessment, risk management actions taken and risk assessment confirming that the identified risks have been reduced to an acceptable level. The results of trials and other documents included in the registration dossiers must confirm the effectiveness of the implemented risk management measures.