The term manufacturer, and who qualifies as a manufacturer as defined in ISO 14971, was updated in the new revision to include more examples to better identify the target audience for the document. This third revision, due to be released soon, was developed with the intent of clarifying and describing in more detail some of the normative requirements such as risk management review and report, production, and post-production information that could and should be used for risk management and evaluation of overall residual risk-all essential to the risk management process. The second edition of ISO 14971 was developed and published in 2007 to address the need for additional guidance on the application of this standard and establish the relationship between hazards and hazardous situations that may arise during the use of a medical device.

The first edition of ISO 14971 was released in 2000 to assist manufacturers, regulatory bodies, and healthcare providers with a framework to manage medical devices’ potential risks and provide a tool to actively improve the safety of medical devices.

Although it is mainly targeted toward the medical device field, the highlighted methods and evaluation points can be effectively applied to a wider array of products not necessarily categorized as medical devices, making it a useful guide for all manufacturers. The scope of the document is to assist medical device manufacturers in identifying the hazards associated with their medical device, estimate and evaluate the associated risks, control these risks, and monitor the effectiveness of the controls through design, production, and post-production phases to ensure patient safety throughout the duration of a product lifecycle. The intent of ISO 14971 is to provide a general “bird’s-eye view” approach to designing and implementing a risk management plan for medical devices, such as risks related to biocompatibility, data and systems security, electricity, moving parts, radiation, and usability. This column will summarize the basic concepts of ISO 14971, highlight the main changes that were made to the document, and provide guidance on what to focus on when evaluating and documenting a medical device for its potential risks. Earlier this year, a final draft of the new ISO 14971: Medical devices- Application of risk management to medical devices came out for voting, and will soon be published as a revised document that will replace the current second edition of the document (ISO 14971:2007).

Medical device risk management template