Sponsors and sites conducting medical device trials will need to include risk-based monitoring and clinical quality management plans in their clinical trial development plans under the upcoming revision of ISO 14155, the international standard on good clinical practices for devices.

The revised standard, ISO 14155:2020, will be published later this year, adding a number of new requirements for device trials, including a focus on risk management throughout the clinical investigation process, a process for escalating unanticipated serious adverse device effects, registration of the trial in a publicly available database and increased attention to statistical considerations.

The update of the standard is intended to harmonize with risk management principles in the new EU-MDR, according to Klaas van ‘T Klooster, chair of the Dutch national standards committee and a member of the international working group that revised 14155.