Europe recognizes ISO 14971:2019, Application of risk management to medical devices

By: Joe Lewelling, Senior Advisor on Content & Strategy

May 23, 2022

Categories: AAMI News, HTM Professionals, Medical Device Manufacturers

A European Union Flag fades into a photo of an operating room

With the recent May publication of Commission Implementing Decision 2022/757 in the Official Journal of the European Union, EN ISO 14971:2019 is labeled as “Harmonized” and listed to the European Union’s Medical Device Regulation (EU 2017/745). When a standard is Harmonized and listed in the Official Journal, manufacturers who comply with the standard are provided with a legal presumption that certain requirements in the referenced regulation have been satisfied. The specific requirements and the extent and limitations of that presumption are detailed European Annexes accompanying the standard.

A companion notice (EU 2022/729) also lists the standard to the European IVD regulation (EU 2017/746) and both decisions modify previous recognitions of ISO 13485:2016, Medical devices—Quality management systems—Requirements for regulatory purposes, for the EU regulations. ISO 14971 is one of the most important standards for the medical device industry and is used worldwide. European recognition was held up by differences in the treatment of “risk” between ISO 14971 and the European Legislation. For Europe, risks must be “reduced as far as possible” without adversely impacting the benefit/risk ratio, whereas ISO 14971 directs that risks be reduced as low as “possible and appropriate.”

These may seem closely aligned, but the European approach mandates an essentially mathematical assessment measured by the benefit/risk ratio, while the ISO standard allows manufacturers to choose from a number of approaches to risk management, including more qualitative ones. The European Annexes for this standard (provided in EU ISO 13485:2016/A[mendment]11:2021) clarify that, for medical devices sold in the EU, the European approach for determining the acceptable level of risk is required.

More on ISO 13485

The U.S. FDA is proposing an alignment of the Quality System Regulation (21 CFR 820) with the international consensus standard for devices, ISO 13485:2016,

Read more about that here.

The Commission Decision also sunsets the listing of the previous 2012 edition of ISO 14971 to the European Medical Device Directives (which were themselves replaced by the 2017 regulation). Essentially, the Commission is declaring EN ISO 14971:2019 with amendment A11:2021 to be the current “state-of-the art” standard that medical device manufacturers should use.

“Manufacturers need to perform a gap assessment of their current risk management practices against the standard and the amendment, identify any shortcomings, and develop an action plan to address them,” explained Ed Bills, a consultant to medical device companies and a lead instructor for the Association for the Advancement of Medical Instrumentation (AAMI) training programs around ISO 13485 and ISO 14971. With respect to EN ISO 13485—the medical device quality management system standard for medical devices—the implementing decisions have added recognition of a European Corrigendum (EN ISO 13485:2016/AC:2018) that corrects formal aspects of the European Foreword and informative annexes.

“Rather than being substantive, this appears to be more administrative tidying up,” added Eamonn Hoxey, PhD, AAMI’s Board Chair Emeritus and the former chair of ISO/TC 210. “Most of the modifications in the corrigendum were in the old Annex Zs that are now replaced by EN ISO 13495:2016/A11:2021.”

Both ISO 14971:2019 and ISO 13485:2016 were developed by ISO Technical Committee 210, Quality management and corresponding general aspects for medical devices. AAMI administers the Secretariat for ISO/TC 210, under the auspices of the American National Standards Institute (ANSI), which is the U.S. member body of ISO.

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