Risk management requirements and guidance documents released for comment

Draft revisions of ISO 14971 and ISO TR 24971 now available for review by national committees

The International Standard ISO 14971:2007 - Medical devices — Application of risk management to medical devices - was adopted as a European standard in 2007. ISO 14971 is a critical horizontal standard supporting the regulation of medical devices. In 2012, the Annexes to this standard that are included in the European adoption, and describe the relationship between the European regulatory requirements and the clauses in the standard, were revised.  These are called Annex Zs to differentiate them from annexes to the base ISO document.  The requirements remained identical to the 2007 international edition of the standard. The European adoption of the standard was reissued as EN ISO 14971:2012.

It was decided in late 2016 that the international standard ISO 14971:2007 would be revised. In parallel, it was decided to also revise ISO TR 24971:2013, the little-known document giving further guidance on ISO 14971. Two documents have now been issued for comment and ballot. These are:

• ISO/CD 14971 Medical devices — Application of risk management to medical devices, and
• ISO TR 24971 ED2 Medical devices - Guidance on the application of ISO 14971.

In ISO 14971, the following changes have been made:

• The defined terms have been updated.
• The requirements have been clarified with more details, in particular regarding
  • overall residual risk,
  • the risk management report, and
  • production and post-production information.
  • More attention is given to the benefits that are expected from the use of the medical device.
  • It is explained that the process described in ISO 14971 can be used for managing all risks associated with the medical device, such as those associated with biocompatibility, infection, data security, electricity, moving parts, or usability.
  • Several informative annexes have been moved from ISO 14971 to the guidance in ISO/TR 24971.

In ISO TR 24971, the text has been reformatted into the same structure and numbering as the clauses and subclauses of the revised ISO 14971. This is intended to make the guidance more useful in understanding and applying the requirements of the standard. Informative annexes contain additional guidance on specific aspects of risk management.

Now is the time to review and provide comments if you want to be able to influence the development of this key standard. Copies of the documents are circulating within National Standards Bodies, including BSI, for review by the national committees that shadow the international work. Comments from the national committees will be consolidated into national positions and submitted to ISO.

Comments submitted on these documents will be considered by the Working Group. If the ballot on ISO CD 14971 is positive, a revised draft based on the results of the consideration of comments will be issued as Draft International Standard (DIS). The drafts will be publicly available at this stage. The DIS text should include drafts of the European Foreword and Annex Zs, showing the relationship between the clauses of the standard and the requirements of the European Directives. We wait to see if the relationship between the clauses of the standard and the Medical Devices Regulation and In Vitro Medical Devices Regulations will also be included at that stage.

Author: Eamonn Hoxey, of E V Hoxey Ltd, UK, is a writer, trainer and consultant on a range of life science areas including regulatory compliance, quality management, sterility assurance and standards development.