It is assumed that ISO 14971 will continue to be an international standard for medical device risk analysis and EN ISO 14971:2012 is harmonized to the MDD. Is any new version of ISO 14971 released soon which is harmonized to the MDR?
EN ISO 14971:2012 is Harmonized with MDR 2017/745
Published On - February 1, 2020
ISO 14971 is the ultimate standard to perform Risk Management of Medical Devices. The first version was released in 2007 and with minor amendments were published in 2009. In July 2012, the European National version of ISO 14971 was released, The European National version identified by the acronym “EN” just before “ISO” in the title.
EN ISO 14971:2012 supports essential requirements of EU Directives 93/42/EEC on Medical Devices, 90/385/EEC on Active Implantable Medical Devices, and 98/79/EC on In Vitro Diagnostic Devices.
The newly updated ISO 14971:2019 standard which is in line with the EU MDR (2017/745) and IVDR (2017/746), the new standard refocuses attention on the benefit-risk analysis of the medical devices.
ISO 14971:2019 is the new version for the Application of risk management to medical devices.
At present, the harmonized version is EN ISO 14971:2012.
Yes, a new version of ISO 14971 was released in December 2019 which is ISO 14971: 2019 Medical devices — Application of risk management to medical devices, and in Europe, the new edition was adopted as EN ISO 14971:2019.
Interestingly, it was read in one of the BSI blogs (published in Feb 2020) that initially a draft of this standard was published by the European Commission which had the European Annex “Z” in the harmonized version EN ISO 14971, which had five Draft Annexes Z. Draft Annexes ZA, ZB, and ZC showed a relationship with the Directives for medical devices and Draft Annexes ZD and ZE showed the relationship between EN ISO 14971: 2019 and chapter 1 of Annex I of MDR and IVDR. However, this was not published in the actual text but has been agreed to include it in a European amendment to the standard. It is stated that the harmonized version emphasizes on the state of the art risk management and supports in complying with the regulations internationally, which can be an important tool in transitioning to MDR and IVDR, even without the above-said European annex Zs.
ISO 14971: 2019 Medical devices — Application of risk management to medical devices is the new version and the harmonized version is EN ISO 14971:2012.
The annexes content in ISO 14971:2007 was moved to Technical Report ISO/TR 24971:2020. There are eight Annexures to ISO/TR 24971:2020 which provides guidance, explanation and examples of the risk management process requirements including the production and post-production section.
ISO 14971: 2019 is a latest version (December 2019) of ISO 14971 for the Application of risk management to the medical devices, which in addition emphasis on Risk Benefit Analysis with inclusion of production and post-production activities.
The EN version of ISO 14971:2019 will not be harmonized with the MDD and not yet formally harmonized with EU MDR, thus not yet replaced with EN ISO 14971:2012.