In the past, medical device manufacturers have used risk acceptance matrices with large green areas where the occurrence of damage was acceptable. Today, this indicates that something is wrong with the risk acceptance matrix. In this article we show you the 4 most common mistakes when using the risk acceptance matrix and how to avoid them.
Mistakes in the Risk Acceptance Matrix
What errors does this risk acceptance matrix contain?
Risk Acceptance Matrix Mistake No. 1:
According to MDR Appendix I, chap. I, paragraph 1, are risks (related to harm to patients/users/third parties) are only acceptable if they are "minimized as much as possible" and "reasonable compared to the benefits". This means that there must be no per se acceptable risks in the risk acceptance matrix about harm to patients/users/third parties. In this form, the green fields are therefore wrong as acceptable per se.
Risk Acceptance Matrix Mistake No. 2:
ALARP is not allowed. The MDR Annex I, chap. Paragraph 1 clearly states that risks must be minimized "as far as possible". Annex C of CEN ISO TR 24971:2020 specifies several approaches. However, here the MDR's legal requirements beat the standard's requirements.
Risk Acceptance Matrix Mistake No. 3:
There are no fields for the acceptable occurrence of catastrophic damage. Since no acceptable occurrence of catastrophic damage can be achieved, it is impossible to bring these risks to an acceptable level. Catastrophic damage is, therefore, never acceptable. The acceptance limit for these damages is not shown.
Risk Acceptance Matrix Mistake No. 4:
For negligible damage, there are no fields for unacceptable occurrence. Negligible damage is always acceptable. Thus, there is no acceptance limit for negligible damage.
How to correctly use the Risk Acceptance Matrix
Conclusion: Mistakes in the Risk Acceptance Matrix
To effectively use the risk acceptance matrix as a tool over the entire area, ensure to avoid these 4 common mistakes.
If you have further questions about the risk acceptance matrix, contact us at office@sifo-medical.com.
Author: Bernhard Lindner, MSc
Are you still having questions about how to use the risk acceptance matrix in a way that complies with the Medical Device Regulation?
Our expert Bernhard Lindner will be happy to support you – contact us at office@sifo-medical.com.
Comments