Regarding thresholds for continuous re-evaluation, this needs to be set commensurate with the risk and complexity of the subject device, and in conjunction with the corresponding mechanism in the risk management process for ongoing re-evaluation of risk (e.g., see EN ISO 14971;2019 clause 10) along with the associated process for updating the clinical evaluation. These mechanisms should have a baseline policy for re-review / reassessment of the benefit-risk ratio at a routine frequency, where that frequency can generally be less for lower-risk devices, and more for higher-risk devices. Then in addition, in order to properly react to emerging quality issues, each time a new/modified risk is identified under the ongoing monitoring called for by EN ISO 14971;2019 clause 10, the benefit/risk ratio should also be considered for reassessment. As far has more technical specifications in a guidance document, I know of none, but would be glad to hear others' input on that.
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Kevin Randall, ASQ CQA, RAC (Europe, U.S., Canada)
Principal Consultant
Ridgway, CO
United States
© Copyright 2021 by ComplianceAcuity, Inc. All rights reserved.
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Original Message:
Sent: 26-Apr-2021 14:56
From: Kevin Randall
Subject: Benefit/risk analysis
It has been my experience that EN ISO 14971:2019 is generally considered to be state of the art for the EU MDR. Accordingly, I've found useful its clause 7.4 and its corresponding guidance in ISO/TR 24971:2020 clause 7.4. Also of note is that recent HAS Consultant output from Europe's ongoing EU MDR harmonization efforts for EN ISO 14971:2019 refers stakeholders to Annex A7.2 of MEDDEV 2.7/1 rev. 4.
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Kevin Randall, ASQ CQA, RAC (Europe, U.S., Canada)
Principal Consultant
Ridgway, CO
United States
© Copyright 2021 by ComplianceAcuity, Inc. All rights reserved.
Original Message:
Sent: 26-Apr-2021 02:36
From: Christian Micheletti
Subject: Benefit/risk analysis
Dear all,
is there a guideline explaining methodologies to perform a benefit/risk analysis under MDR, and to identify the related thresholds for continuous re-evaluation? I had a look to the FDA guideline, but it is quite generic. I was looking for some technical specifications.
Thank you very much
C.
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Christian Micheletti
Project Manager; Regulatory Affairs expert
Nouvag AG
Zurich
Switzerland
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