Risk Management is Integral throughout the IVD Product Development Life Cycle

​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:

• New and updated terminology to reflect current industry verbiage such as “benefit,” “reasonably foreseeable misuse” and “state of the art”.
• Clarification that the standard can be used as a: “guidance for developing and maintaining a risk management process that is not necessarily medical devices”[1]; for example for accessories or non-medical products that are used in conjunction with a medical device.
• Alignment with other standards to support the medical device life cycle including clinical investigations (ISO 14155), usability engineering (EN 62366) and quality management system (QMS) (ISO 13485).
  • Clinical processes will review the inherent residual risks that remain as they relate to the clinical benefits of the device
  • QMS, the manufacturer will review the “state of the art” and suitability of the medical device for its intended use
  • Usability engineering will review the potential hazards for all users, including the patient, health care provider/caregiver, health professional and other persons that support the use of the medical device.
• Reinforcement of a separate risk plan and post-production verification activities, similar to the corrective and preventive action (CAPA) process. The clarification requires preparation and post-implementation activities to verify whether issues were resolved effectively using the change control process and continuous improvement process.  The methodology for evaluating overall residual risk and acceptability criteria will need to be included within the plan.
• “Reasonably foreseeable misuse”is also reinforced as an approach to mitigating residual risk and asking the manufacturer to address potential design errors and the predictable nature of the hazard. 

This standard also discusses the need to review collected information and determining its relevancy to safety;  the review of risk management and determination if (re)-assessment of (new) risks are necessary, evaluation of the impact on previous risk controls and activities, and actions for legacy and competitor devices currently on-market.

Timelines
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[2]. 
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 kelly@boudiccadx.com for further details about Boudicca Dx LLC.’s capabilities.
 


[1]ISO 14971:2019

[2]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