The risk management process is the central factor in developing a safe and effective medical device to use, this process allows medical equipment companies to develop safe and life-saving devices. Recently, the standards for risk management of medical equipment - 14971ISO and 24971 TR were updated to improve different stages in the management process.
These changes are important to recognize and relevant for all medical device manufacturers.
ISO 14971 is a standard for applying risk management to medical devices that provides a risk management system for all medical equipment, including in vitro diagnostic equipment. This system supports manufacturers in order to define risks related to medical equipment, identify and assess risks and control them. Within the framework of the standard there are requirements concerning all stages of the product life cycle. Adopting this standard at an early stage in the planning process will help the manufacturer to ensure that his medical equipment complies with EU regulations and to enter the global market with a medical device efficiently and safely. This standard obliges the manufacturers of medical equipment to establish objective criteria for the acceptance of risks although it does not specify the acceptable risk levels.
The update of the 14971:2007ISO edition to the 14971:2019ISO standard was made mainly for the following reasons:
Ambiguity of the instructions regarding risk management, the appearance of outdated regulations in the standard as well as the adaptation to the new regulation for medical devices in Europe (IVDR/MDR) and the 2016 edition of the ISO 13485 standard.
The risk management process itself remains almost unchanged. However, there are important clarifications and updates in the 2019 edition of the ISO 14971 standard that you should be aware of. The main changes between the releases are:
ANNEX A - remains unchanged as its role is to clarify the rationale for the requirements of the standard. ANNEX B - This appendix previously included a flowchart of the review of the risk management process and now in the 2019 edition contains the risk management process for medical devices as well as a table of adjustments between the 2007 and 2019 editions of the standards. ANNEX C - This appendix has changed and is now a guide to dangerous events and situations that may happen, examples of dangers and more.
The 24971 TR standard includes guidelines for risk management for in vitro diagnostic devices (IVDR), risk management plans, risk concepts and techniques, and guidance on hazard identification. These guidelines appeared in the ISO 14971 standard, 2007 edition before the update to the new edition - 2019.
Referring to the recommendations of the ISO Council, the Technical Committee (JWG1), decided that informative appendices will appear mainly in ISO TR 24971 therefore, in the 2020 edition of the standard, new appendices have been included in order to cover various relevant topics among the new appendices you can find the following:
Medical Device
Cosmetics
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