New Revision of ISO 14971 Coming Soon

by | Aug 9, 2019 | EU, EU MDR, FDA, ISO, Regulatory

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.1

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.2

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.1

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.


1BSI (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-completes-formal-vote/?utm_source=pardot&utm_medium=email&utm_campaign=SM-SUB-LG-HLTH-CN_blog-2019

2BSI (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

Nikita Angane

Nikita Angane

Solutions Delivery Specialist - Ms. Angane is a Bioengineering graduate with experience in medical device commercialization, product development, quality system compliance and regulatory affairs. Her portfolio includes working on medical devices, combination products, and pharmaceuticals. As a Solutions Delivery Specialist at EMMA International, she offers her expertise to help our clients achieve an effective and sustainable quality system, and develop regulatory strategies for market access and compliance of new products in the US and international markets. Ms. Angane earned a Bachelor of Engineering in Biomedical Engineering from the University of Mumbai, India and an M.S. in Bioengineering from University of Illinois at Chicago.

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