Risk management file according MDR or ISO 14971:P2019 ?

[Doninina]

Hi every one
I have a question about risk management report , our risk management file is in compliance with ISO 14971:2012 , and now we want to update our risks file according to ISO 14971:2019 , which items should be changed in the updated version according to ISO 14971:2019 ?
and one another question , should our risk management file be in compliance with MDR or ISO 14971?
its so nessecary for me if anyone can help me in this item.

 

[EmiliaBedelia]

our risk management file is in compliance with ISO 14971:2012 , and now we want to update our risks file according to ISO 14971:2019 , which items should be changed in the updated version according to ISO 14971:2019 ?

There were quite a few updates from 2012 to 2019. The best way to do this is to buy the updated version of the standard and assess it for yourself, as the changes you need to make will vary a lot based on your specific company/documentation.

and one another question , should our risk management file be in compliance with MDR or ISO 14971?

These are not mutually exclusive. Your risk management file should be in compliance with both. ISO 14971 has now been harmonized to MDR, so look for the A11:2021 version which will include the informative ZA annex describing the application of the standard to the GSPRs.

 

[RA_QA_Expert]

Hello, as mentoned above look into A11:2021 to see relation between MDR and ISO14971. If you see any discrepancies, EU MDR/GSPR requirement is mandatory.

Version 2019 includes no significant changes in comparison witn 2012 version, but it is recommended to read also ISO/TR 24971 Guidance how to use ISO 14971. NB's are asking for consideration of this Technical Report.

Any decision or direction within desing and development must be evaluated from risk-benefit point of view and the biggest though behind is that clinical benefits of medical device are higher than residual risks.

Although verion 2019 brings no significant changes, also other standars are updated for better connection with risk management (e.g. IEC 60601-×-x series) and strong connection between risk management, clinical evaluation, usability and others are requested also by MDR.

Good luck with improvement of your QMS.