Nov 28, 2018


  • The anticipated update to ISO 14155 in 2019 includes stronger requirements for clinical risk management.
  • The third edition of the ISO 14155 medical device clinical investigation standard will align more closely to ISO 14971 medical device risk management concepts.
  • Quality management principles applied to clinical investigation audits are also introduced in ISO 14155’s latest edition.

A stronger emphasis on risk management in the ISO 14155 medical device clinical investigation standard’s latest edition has manufacturers and sponsors reassessing their pre- and post-market clinical practices ahead of the revised standard’s 2019 publication timeframe.

Below, Emergo by UL clinical consultants in Germany note three key risk-management related components of ISO 14155 Third Edition.

The clinical quality management concept

First, the third edition of the standard adds “clinical risk management” to the list of sponsor responsibilities, which both introduces the concept of clinical quality management processes and requires study sponsors to implement them.

“This chapter of the third edition refers to ISO 13485 certification, which is a target for most medical device manufacturers,” explains Aleksandra Klimaszewski, Manager of Clinical Affairs at Emergo Clinical BV. “So, the fact that the scope of quality management will have to expand to clinical operations makes sense.”

Tying ISO 14971 more closely to medical device clinical investigations

The third edition of ISO 14155 also more explicitly reinforces risk management throughout clinical investigation processes via references to the ISO 14971 standard that applies risk management to medical devices.

The current version of ISO 14155 only makes reference to ISO 14971 in terms of investigational device risks, and to support risk-benefit assessments to meet clinical investigation design rationale requirements.

Quality management and clinical investigation audits

Third, the latest edition of ISO 14155 introduces the concept of clinical investigation audits of sponsors, investigators and sites in terms of not only Good Clinical Practice (GCP) but also clinical quality management processes.

“By adding additional guidance on requirements for such audits, the latest version of ISO 14155 is emphasizing the importance of oversight by sponsors—even or especially if this task is outsources to a third-party clinical research organization,” Klimaszewski observes.

Related medical device clinical resources from Emergo by UL:



  • Stewart Eisenhart