Jan 14, 2020

The US Food and Drug Administration has granted Recognized Consensus Standard status to the third edition of the ISO 14971 risk management standard for medical devices and IVD products.

FDA’s recognition of ISO 14971 Third Edition 2019-12 will entail a transition from the standard’s previous edition, ISO 14971 Second Edition 2007-03-01, through late 2022.

ISO 14971 declarations of conformity and FDA premarket submissions

Accordingly, the agency will accept declarations of conformity to ISO 14971 2nd edition included in medical device and IVD premarket submissions until December 25, 2022; from that point on, FDA medical device and IVD registrants will be required to provide declarations of conformity to the standard’s third edition.

ISO 14971 general scope

In general, the ISO 14971 standard applies risk management requirements across all stages of a device’s lifecycle, although without identifying acceptable risk levels or requiring quality management system implementation by manufacturers. Emergo by UL will provide deeper analysis of ISO 14971 3rd edition requirements and updates in the near future.

Mark Leimbeck is Chair of the UL Health Sciences Council.

Related medical device and IVD risk management resources from Emergo by UL:

  • ISO 14971 risk management consulting for medical device manufacturers
  • Training to ISO 14971 for medical device companies
  • Webinar: Practical implications of EU MDR and ISO 14971 on post-market surveillance