The new ISO 14971 3rd edition was released for sale by ANSI / AAMI on December 16, 2019, and as a member of AAMI, the cost is $133.
In October of 2018, I wrote a blog on the draft version of ISO 14971 3rd edition of the risk management standard for medical devices. That article explained the differences between the different versions of the ISO 14971 standard (i.e., 2000, 2007, 2009, and 2012). I also explained what changed between ISO 14971:2007 and ISO/DIS 14971:2018–the 2018 draft of the standard that was released this week.
The changes proposed in the draft included subtle changes to the names of the processes and a minor adjustment to the numbering of the clauses. Many of the annexes were also moved to ISO/TR 24971 guidance–which has not yet been released. The draft did not, however, result in a change in the overall process of risk management.
All of the changes that were discussed in my 2018 review were maintained in the final 2019 version that was released, but the ISO/TR 24971 guidance was not released at the same time as the committee had hoped for.
There are not any surprises in the 3rd edition (i.e., 2019 version). Therefore, I plan to wait until the ISO/TR 24971 guidance is released and then prepare a new blog specific to the guidance. If you are interested in training on the ISO 14971:2019 standard, the training I recorded on October 19, 2019, provides an excellent overview of these changes and highlights some of the challenges that you will encounter when trying to harmonize your risk management procedure between the ISO 14971:2019 standard and Regulation (EU) 2017/745.
If you want to know when the new guidance is released, please subscribe to my blog, and you will receive an update as soon as I can purchase the new guidance. Once the new guidance is released, I will also be providing a new risk management training bundle for $499 that includes the following:
- ISO 14971:2019 risk management training webinar – recorded October 2019
- Risk Management Procedure (SYS-010) that will be updated for the 2019 version (no cost for updates to our procedures)
- ISO/TR 24971:2020 risk management training webinar – February 10, 2020
- Risk Management Training Exam that will be updated for the 2019 version (no cost for updates to exams)
- A signed training certificate and a corrected exam
This is a lot of information to absorb. Therefore, I recommend purchasing the October 2019 webinar and your copy of the ISO 14971:2019 standard from AAMI. Anyone that has already purchased either the webinar or the procedure will receive an email offering them a discount on this new bundle that credits them for their previous purchase. If you have purchased both, you will receive credits for both purchases. Just think you can watch the video and read the new version of the standard while you are working out at the gym in January. Learn and burn!