While Dan talks about ISO 14971:2019, a better reference is ISO TR 24971:2020 for a complete discussion of various aspects of the benefit-risk requirements of ISO 14971:2019. Overall, though, the technical committee wrote the requirements in the standard and the information in the technical report in such a way to address the requirements of the MDR and IVDR. We also added a definition for the term "benefit" which is undefined by any regulatory body, including EU. Since there is no harmonized standard for either MDR or IVDR you must, however, provide the necessary documentation to demonstrate to the Notified Body that you meet the requirements of the regulation. That is leading to lots of confusion today.
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Edwin Bills MEd, CQA, RAC, BSc, CQE, ASQ
Principal Consultant
Overland Park KS
United States
elb@edwinbillsconsultant.com------------------------------
Original Message:
Sent: 20-Aug-2020 06:34
From: Richard Vincins
Subject: Benefit Risk Analysis- IVDR
Hello Anon,
You are asking a question quite involved and much more information than could probably be supplied in a short forum post. We conduct training on Risk Management and the benefit/risk analysis is a few hours of discussion and working through examples. This also unfortunately is a mis-understood topic, not applied consistently, and even though the EU IVDR and EN ISO 14971:2019 standard have information about this - there are many interpretations around what is "benefit versus risk analysis." Then it is more complicated because benefit/risk analysis profile of IVD products is quite different from standard medical devices. Then the application of clinical benefit versus risk profile of a device can be viewed differently in the regulation as compared to the standard. You can in fact create separate Risk Benefit Analysis documents or so called RBA documents as people like to call them. Or you can have the benefit/risk analysis in the risk management report itself. Or maybe even have it contained in the CER referencing the RMF/RMR. There is not one consistent way to do this, so what is important is you define in your own QMS processes how you manage, detail, analysis, and summarise the benefit versus risk analysis profile of your device/device family.
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Richard Vincins RAC
Vice President Global Regulatory Affairs
Original Message:
Sent: 19-Aug-2020 19:16
From: Dan O'Leary
Subject: Benefit Risk Analysis- IVDR
Start by stating the requirement. Because your title includes IVDR, I infer you are asking about the IVDR and not about EN ISO 14971:2019. (If this is not the case, I'll have a different answer.)
I'll also comment that in both the IVDR and the MRD the authors had concepts in mind that are not clear in the wording of the regulation. The benefit/risk area is one of them.
Start with Annex I(1) which requires that devices don't compromise the clinical condition, health, or safety of users, patients, or others, "provided that any risks which may be associated with their use constitute acceptable risks when weighed against the benefits to the patient".
The requirement here is from the patient's point of view and suggests balancing (weighing) patient risks against patient benefits. I suggest this is the source the undefined concept of the benefit-risk ratio. By analogy, putting the benefits and the risks on a balance scale, the benefits exceed the risk. (The ratio favors the benefits.) The method is the benefit-risk determination in Article 2(17) which is the analysis of all benefits and all risks.
Because we are in the IVDR and not EN ISO 14971:2019, take benefit as clinical benefit defined in Article 2(37).
Annex I(8) broadens the situation. It requires minimization of risk and undesirable effects and risk acceptability when weighed against benefits to patients or users. The same general method of benefit-risk determination applies.
For the IVDR, consider self testing, near patient testing, and companion diagnostics, since the roles of the patient or and user may become involved.
In the end, benefit risk determination comes down to listing all the benefits of the device and all the risks of the device. For risks, use overall residual risk from EN ISO 14971:2019.
Determine some method to weight benefits against risks, document it, use it.
For PMS, using Annex III(1)(b) determine suitable indicators and threshold values for benefit-risk analysis reassessment.
Now, to your specific questions.
Can we create a section in the Risk Management report on Benefit risk analysis?
It is already required by EN ISO 14971:2019, 9 second indent.
Are we expected to state an overall benefit risk analysis or benefit risk analysis for each individual residual risks?
No. In EN ISO 14971:2019 benefit-risk analysis is an exceptional case when the residual risk or overall residual risk is not acceptable using the criteria in the risk management plan. See sections 7.4 and 9. EN ISO 14971:2012 had some strange content deviations in this area, but, for the IVDR and MDR, it is obsolete.
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Dan O'Leary CQA, CQE
Swanzey NH
United States
Original Message:
Sent: 18-Aug-2020 19:10
From: Anonymous Member
Subject: Benefit Risk Analysis- IVDR
This message was posted by a user wishing to remain anonymous
Risk experts,
I am wondering if you can shed light on what's expected by Notified Bodies on the Benefit Risk Analysis requirement?
I am working with few consultants, they are creating a stand alone document ( lengthy) with lot of copy paste from the Risk Management plan and report including clinical report. Can we create a section in the Risk Management report on Benefit risk analysis? Are we expected to state an overall benefit risk analysis or benefit risk analysis for each individual residual risks?
Any idea how this requirement is best handled?
Thanks for your time!!