At the end of 2019, the International Organization for Standardization (ISO) released the revised standard on the “Medical devices - Application of risk management to medical devices”, which provided clarifications and additions from the previous version. This standard has been accepted by at least 34 European members and is a recognized consensus standard by the US FDA as of late December.
These are some highlights:
ISO 14971:2019 is released with a grace period for execution and compliance of June 20, 2020.
In regard to the transition to ISO 14971:2019, FDA will accept declarations of conformity (“Required Elements for a Declaration of Conformity to a Recognized Standard) to the previous version, ISO 14971:2007, in support of premarket submissions until 25 December 2022.
With the issuance of ISO 14971:2019, industry is anxious to see what type of impact this will have on other standards that require a risk management system foundation such as IEC/EN 62304 Medical Device - Software Life Cycle Processes.
Boudicca Dx, LLC has the expertise to support and assist medical device companies with maneuvering through the current and updated guidances, rule-making, and legislation changes that can impact your quality management, assay development, clinical and regulatory infrastructure.
Reach out to firstname.lastname@example.org for further details about Boudicca Dx LLC.’s capabilities.
Recognized Consensus Standard. Date of Recognition from FDA for ISO 14971:2109 - Medical Devices - Applications of Risk Management To Medical Devices. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfstandards/detail.cfm?standard__identification_no=40369