Clinical evaluation interface with the risk management process

Mike Towers

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Hello everyone,
I have a CE Marking Audit according to the MDR soon, within the documentation they request I have to prepare "Procedure for clinical validation", within which there must be a section that deals with the following:
- The interface with the risk management process,
 
Are you following ISO 14155? Are you following ISO 14971? Are you following the latest versions? The connection is pretty clear in these standards.
 

Mike Towers

Involved In Discussions
Thank you for your response.
My question was about how the Clinical Evaluation and Risk Management processes feed back.
That is, how would a variation in the Global Residual Risk Assessment affect the Clinical Assessment, for example.
 
What do you mean by "variation"? If there is a new, previously unidentified risk, regardless of the source, it could affect the benefit-risk analysis, which in turn could mean that the clinical study should be on hold or terminated. Can you ask your question in a more specific way?
 

Junn1992

Quite Involved in Discussions
You just need to show the connection between your risk management plan and the CER. Eg:

1. Design phase: Risk Management Version 1
2. After pre-clinical testing: Risk Management version 2 (some new risks identified)
3. During clinical testing: Risk management version 3 (some usability issues identified)
4. Post clinical testing and final evaluation for clinical evaluation report: Risk management version 4
================
5. Post market: Risk management version 5 (issues detected post market) etc. etc.
 

Mike Towers

Involved In Discussions
What do you mean by "variation"? If there is a new, previously unidentified risk, regardless of the source, it could affect the benefit-risk analysis, which in turn could mean that the clinical study should be on hold or terminated. Can you ask your question in a more specific way?
Exactly what the Auditor asked for is:
Your quality system must include procedures and documentation related to device clinical evaluation which adequately address:
- the interface with the risk management process
 

Mike Towers

Involved In Discussions
Thanks for your quickly reply!
And once the Clinical Evaluation Report and the Risk Management Report have been carried out, what would be the input that would cause the clinical evaluation report to have to be modified?
 

Junn1992

Quite Involved in Discussions
And once the Clinical Evaluation Report and the Risk Management Report have been carried out, what would be the input that would cause the clinical evaluation report to have to be modified?

Under the MDR, there are many things that could possibly cause an update to the CER, but I think you are specifically asking about Risk Management.

Typically, whenever new risks are identified, the risk management file/section gets updated. And because the risks are updated, you are then required to re-evaluate the benefit-risk determination of the device overall, which translates into an update of the CER.
 

Mike Towers

Involved In Discussions
Thanks @Junn1992
I wanted to know your opinion, the CER will only be updated in case the new risk detected changes the Benefit/Risk ratio, is that correct?
In other words, if control measures can be implemented for the detected risk, so that its severity and frequency can be considered as acceptable, I understand that it would not be necessary to update the CER, since the benefit/risk ratio did not change, is that so?

Thank you,
 

Junn1992

Quite Involved in Discussions
Thanks @Junn1992
I wanted to know your opinion, the CER will only be updated in case the new risk detected changes the Benefit/Risk ratio, is that correct?
In other words, if control measures can be implemented for the detected risk, so that its severity and frequency can be considered as acceptable, I understand that it would not be necessary to update the CER, since the benefit/risk ratio did not change, is that so?

Thank you,

The CER would still need to be updated since the information contained in risk management has changed, and control measures have been implemented. In this scenario, implementing a control measure might also result in updating your IFU's, which also affects the technical file.
 
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