Risk management standard completes formal vote

New edition of EN ISO 14971 completes final approval ballot

ISO 14971:2007 - Medical devices - Application of risk management to medical devices - is a critical horizontal standard supporting the regulation of medical devices. It was decided in late 2016 that the international standard ISO 14971:2007 would be revised. The revision process has now completed all its comment and ballot stages. The technical content is now fixed and only editorial corrections are permitted. It is expected that the new edition will be published in the third quarter of this year.

The final ballot of this standard was conducted in parallel in Europe. The European adoption of the International standard, EN ISO 14971, should be published at the same time as the ISO version. The European adoptions of the standard will incorporate annexes showing the relationship between the standard and the General Safety and Performance Requirements (GSPRs) of the European Directives for medical devices and the Regulations for medical devices (MDR) and in vitro diagnostic medical devices (IVDR). 

The regulatory requirements in Europe for a risk management system are given in Chapter 1, General Requirements, of Annex I of the MDR and IVDR where the GSPRs are set out. EN ISO 14971 indicates that it covers the general requirement to establish, implement, document and maintain a risk management system that is a continuous process throughout the lifecycle of the medical device. For the detailed requirements in the MDR and IVDR, EN ISO 14971 indicates that it covers the risk management process requirements.

Several informative annexes that were included in the previous edition of ISO 14971 have been moved to the separate guidance document, ISO/TR 24971- Medical devices — Guidance on the application of ISO 14971. ISO/TR 24971 is being revised in parallel and a significant expansion of the guidance is being undertaken. ISO/TR 24971 has the same structure and numbering of clauses as the revision of ISO 14971. Guidance is provided to help understand and implement each requirement in ISO 14971. This new structure should make the guidance more relevant and easier to navigate. A second comment period on the draft of this guidance document is being conducted. With the finalisation of the requirements in ISO 14971, the guidance in ISO/TR 24971 can now be completed and the alignment between the requirements and guidance ensured. It is expected that ISO/TR 24971 will be published in the fourth quarter of 2019.

Understanding the current expectations for a risk management system is a critical element of meeting regulatory requirements. The content of this new edition of EN ISO 14971, and the guidance in ISO/TR 24971, provide important support to assist in complying with regulations internationally. These documents can be important tools in transitioning to the MDR and IVDR. As you are revising your Technical Documentation to the new European requirements, it will be essential to make sure that your risk management documentation, including risk management plans and risk management files, meet these current expectations.

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