BS EN ISO 14971:2019+A11:2021

Medical devices. Application of risk management to medical devices

What is this standard about?

Recognized by regulatory authorities in the US, Canada, Europe and more, this international standard helps medical device manufacturers establish, document and maintain a systematic risk management process across all phases of the lifecycle of a medical device. Use of the standard helps streamline the regulatory processes that enable entry to selected markets.

Who is this standard for?

It will be used by all parts of the medical device industry, and by organizations dealing with the design, development, production, installation or servicing of medical equipment, devices and technology.

Why should you use this standard?

BS EN ISO 14971 specifies terminology, principles and a process for medical devices risk management, including software as a medical device and in vitro diagnostic medical devices.

The process described will help medical device manufacturers:

• Identify the hazards associated with the medical device
• Estimate and evaluate the associated risks
• Control these risks
• Monitor the effectiveness of the controls

The standard's requirements apply to all phases of the life cycle of a medical device. The process described applies to risks associated with a medical device, such as those related to biocompatibility, data and systems security, electricity, moving parts, radiation and usability. It can also be applied to products that are not necessarily medical devices in some jurisdictions and can also be used by others involved in the medical device lifecycle.

NOTE 1: This document does not apply to decisions on the use of a medical device in the context of any particular clinical procedure or business risk management.

NOTE 2: The standard requires manufacturers to establish objective criteria for risk acceptability but does not specify acceptable risk levels.

NOTE 3: Risk management can be an integral part of a quality management system. However, this standard does not require the manufacturer to have a quality management system in place.

What's changed since the last update?

This is a revision of ISO 14971:2007 (BS EN ISO 14971:2012). It improves the information on the implementation of the risk management process. In particular:

• More attention is given to the expected benefits of using the medical device. The term benefit-risk analysis has been aligned with terminology used in some regulations
• The method for evaluating the overall residual risk and the acceptance criteria are to be defined in the risk management plan
• The review before commercial distribution of the medical device concerns the execution of the risk management plan. The results of the review are documented as the risk management report.

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