ISO 14971:2019 summary

ISO 14971:2019 is an international standard that outlines the principles and requirements for
risk management of medical devices. Here are the main points of ISO 14971:2019:

Scope and Application:

The standard applies to the entire life cycle of a medical device, from design and
development to production, distribution, and post-market activities.

Risk Management Process:

ISO 14971 emphasizes a systematic approach to risk management throughout the product life
cycle.
It provides a framework for identifying, assessing, evaluating, and controlling risks
associated with medical devices.

Risk Analysis:
Manufacturers are required to conduct a risk analysis to identify potential hazards and
estimate the associated risks.
The analysis should consider both the probability and severity of harm that may result from a
risk.

Risk Evaluation:
The standard guides manufacturers in evaluating the identified risks to determine if they are
acceptable or if further risk control measures are necessary.

Risk Control:
ISO 14971 emphasizes the importance of implementing risk control measures to reduce or
eliminate identified risks.
Risk control measures should be proportionate to the risk and take into account the state of
the art, available technology, and the intended use of the device.

Residual Risk:
Residual risks, which are the risks remaining after the application of risk control measures,
should be assessed to ensure they are acceptable.
Benefit-Risk Analysis:
Manufacturers are required to conduct a benefit-risk analysis, considering the intended use
and medical benefits of the device against the residual risks.

Risk Management Report:

A comprehensive risk management report should be prepared and maintained throughout the
product life cycle. This report documents the entire risk management process.

Post-Market Surveillance:
ISO 14971 emphasizes the importance of ongoing post-market surveillance to identify and
evaluate risks that may arise during the device's use in real-world conditions.

Documentation and Record-Keeping:

Manufacturers should maintain documentation of the risk management process, including
records of risk analyses, evaluations, and decisions.

Communication:
Effective communication is crucial throughout the risk management process, both within the
organization and with relevant external parties.
ISO 14971:2019 is designed to help manufacturers systematically manage risks associated
with medical devices to ensure their safety and effectiveness throughout their life cycle.

What documents are required?

ISO 14971:2019 outlines specific documentation requirements to support the risk
management process for medical devices. The required documents include:

Risk Management Plan:

A comprehensive plan that outlines how the risk management process will be conducted
throughout the lifecycle of the medical device. It includes details on roles and
responsibilities, methods, criteria for risk acceptability, and a schedule for reviewing and
updating the risk management activities.
Risk Management File:

A compilation of all documents related to the risk management process. This file should
include the risk management plan, results of risk assessments, records of risk control
measures, and documentation of the benefit-risk analysis.
Risk Analysis Report:

Documents the results of the risk analysis, including the identification of hazards, estimation
of the probability and severity of harm, and the initial risk assessment.
Risk Evaluation Report:

Describes the process of evaluating identified risks, determining their acceptability, and
deciding on the need for additional risk control measures.
Risk Control Measures Documentation:

Details the risk control measures implemented to mitigate or eliminate identified risks. This
documentation should include the rationale for selecting specific measures and evidence of
their effectiveness.
Residual Risk Assessment:

Documents the assessment of residual risks remaining after the application of risk control
measures. It includes an evaluation of whether the remaining risks are acceptable.
Benefit-Risk Analysis:

A report that assesses the overall benefit-risk balance of the medical device. It considers the
intended use, medical benefits, and residual risks, providing justification for the acceptability
of these risks.
Post-Market Surveillance Plan:
Outlines the procedures and methods for ongoing monitoring of the medical device's
performance and the collection of data to identify and assess potential risks in the post-market
phase.
Post-Market Surveillance Reports:

Documents the results of post-market surveillance activities, including any new information
related to the device's safety and performance, and how it influences the risk management
process.
Risk Management Report:

A comprehensive report that summarizes the entire risk management process, including the
risk management plan, risk analysis, risk evaluation, risk control measures, residual risk
assessment, benefit-risk analysis, and post-market surveillance findings.
These documents collectively provide a thorough record of the risk management activities
undertaken by the manufacturer and contribute to the ongoing assessment and improvement
of the safety and effectiveness of the medical device. It's important for manufacturers to
maintain these documents throughout the entire lifecycle of the device.