December 10th, 2019, the new “ISO 14971:2019 Medical devices — Application of risk management to medical devices” was published and has been made available for purchase. The new revision is a very important tool in your transition to the new Medical Device Regulation (MDR) and/or In Vitro Diagnostic Regulation (IVDR). As you are revising your technical documentation to meet the new regulatory requirements, it will be essential to make sure that your risk management file meets the new expectations.
ISO 14971 is the gold standard for risk management for medical devices and in vitro diagnostic medical devices. It was originally developed to provide manufacturers a process to assist in identifying the hazards associated with their devices, the health risks they possess and how to effectively mitigate them.
The new revision to the standard includes small changes in definitions, new terms, and more detailed requirements around evaluating overall residual risk versus the criteria for acceptability for overall residual risk defined in the Risk Management Plan.
It also refocuses the standard on Benefit-Risk analysis, which is in line with the requirements set out in the MDR and IVDR.
There will be a transitional period of 3 years to allow the manufacturers to adopt the standard.
Should you want to discuss this more in depth with one of our consultants, please do not hesitate to get in touch with us.
You can also enrol in our Qarad Academy on how to set-up your Risk Managament System.
