The second edition of the application guide ISO 14971 “Medical Devices – Application of risk management to medical services” was published last June 2020. It is a worldwide-accepted ISO standard for the application of risk management to Medical Devices.

This second edition invalidates and replaces the first edition.

The ISO 14971 application guide has been published
The ISO 14971 application guide has been published

What are the main changes from the previous edition?

  • The clauses of ISO/TR 24971:2013 and some informative annexes of ISO 14971:2007 have been restructured, technically revised and supplemented with additional guidance.
  • To facilitate the use of this guide, the same structure and numbering of clauses and sub-clauses is used as in ISO 14971:2019. In addition, there are informative annexes containing further guidance on specific aspects of risk management.

ISO 14971: who is this guide for?

The ISO 14971 application guide assists Manufacturers in developing, implementing and maintaining a risk management process for Medical Devices, which aims to meet ISO 14971:2019 requirements. The application concerns a wide variety of Medical Devices, such as implantable and non-implantable devices, active and non-active devices, software as a medical device and IVDs.

In addition, this risk management process is part of the ISO 13485:2016 Quality Management System. There are, in fact, some requirements of ISO 13485:2016 that are related to risk management and can be met by applying ISO 14971.

To evaluate the applicability of this document’s guidance, it is important to consider the nature of the Medical Devices to which it will apply, by whom and how these devices will be used, and what the applicable regulatory requirements are.

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