ISO 14971 is the ultimate gold standard for risk management for medical devices. It was developed to provide manufacturers a process to assist in identifying the hazards associated with their devices, the health risks they possess and how to effectively mitigate them...

1. New Revision of ISO 14971 Coming Soon
By: Nikita Angane, MS
ISO 14971 is the ultimate gold standard for risk management for medical devices. It was
developed to provide manufacturers a process to assist in identifying the hazards associated with
their devices, the health risks they possess and how to effectively mitigate them.
The first version was released in 2007 and a minor update was published in 2009. The European
harmonized version released in 2012, EN ISO 14971 was adopted by the European Commission.
To learn more about the EN ISO 14971:2012, read our blog APPLICATION OF RISK
MANAGEMENT TO MEDICAL DEVICES IN THE EU.
The third edition of this standard is set for its release in Q4 of 2019 along with its technical
report [ISO 24971] that provides guidance to the industry on the application of ISO 14971. The
informative annexes have been moved to the guidance document ISO 24971 and have the same
structure and numbering of clauses as the standard itself. There will be a transitional period of 3
years to allow the manufacturers to adopt the standard. The European adaption of the standard
should also be published around the same time.i
The European standard will show relationships to the new EU MDR. The EN ISO 14971
indicates that it covers the requirement to maintain a risk management system compliant with the
EU MDR.
The relationship of ISO 14971 with ISO 31000, which is an international standard for enterprise
risk management, is also a concern. ISO 14971 has a definition of risk very specific to the
medical device industry, whereas ISO 31000 has a very broader definition of risk.ii
The new revision is a very important tool if you are considering transitioning to the new EU
MDR. As you are revising your Tech File, it will be essential to make sure that your risk
management file meets the new expectations.
The revision process has completed all its comment and ballot stages and the technical content is
confirmed. We will have to wait and watch the new expectations that have been added.i
Have more questions? Or, are you struggling with the risk documentation for your device? Call
us at 248-987-4497 or email us at info@emmainternational.com.
i BSI (July 2019) Risk management standard completes formal vote retrieved on 08/01/2019 from
https://compliancenavigator.bsigroup.com/en/medicaldeviceblog/medical-device-risk-management-standard-

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completes-formal-vote/?utm_source=pardot&utm_medium=email&utm_campaign=SM -SUB-LG-HLTH-CN_blog-
2019
ii BSI (Feb 2017) Is there a risk in revising the risk management standard,ISO 14971, for medical devices? retrieved
on 08/01/2019 from https://compliancenavigator.bsigroup.com/en/medicaldeviceblog/risk-management-
standards/?_ga=2.215992471.1422918310.1516282588-669076282.1486580000