Hello Carole,
I agree with Richard; at RQM+, we've encountered considerable confusion regarding the demonstration of similarity and the uses of similar device data, particularly how these differ between equivalent and similar devices. To my knowledge, we have not received or seen feedback wherein a notified body reviewer requested the demonstration of similarity to mimic that of equivalence. Although some characteristics are shared between these processes, the purposes of clinical data from equivalent and similar devices varies, even in the presence of a standard of care (i.e., well-established technologies) argument. While clinical data from an equivalent device supports the safety and performance profile of the device under evaluation (DUE), such data from similar devices is used to support the profile of a generic device group, without reflecting specific characteristics. If a standard of care argument cannot be made or is rejected by the notified body reviewer, then use of similar device data may still be used for other purposes. In MDCG 2020-5, a variety of such purposes are listed and include the identification of relevant and specified clinical outcome parameters as well as the definition of minimum requirements for a quantified clinical benefit and acceptable occurrence rates of adverse events and risks.
At RQM+, we treat equivalent and similar devices very differently. While the demonstration of equivalence is undertaken using the table provided in MDCG 2020-5, similarity is demonstrated by comparison of those characteristics listed in the MDCG 2020-6 definition of similar devices, namely intended purpose and technology. While clinical data from an equivalent device is identified and tabulated in the DUE review, such data and processes relevant to similar devices is undertaken as part of the state of the art (SotA) review. In creating such a clear distinction between our methods for establishing and collecting clinical data for equivalent and similar devices, we hope to avoid misunderstandings regarding their purposes and expected levels of evidence.
Regarding uses of clinical data from similar devices, at RQM+ this can vary depending on the route of conformity (e.g., use of standard of care argument or if clinical data is not deemed appropriate). In the SotA review, clinical data from similar devices (as available) is collected, tabulated, and aggregated into ranges of outcomes relevant to the generic device group. If a standard of care argument is proposed, we use these ranges for 2 purposes: 1) to establish minimum requirements for quantified benefit or maximum acceptable occurrence rates of adverse events and risks, and 2) to show that the generic device group is safe and performs as intended. If a standard of care argument is not proposed or is rejected by the notified body reviewer, then the latter purpose is precluded, except to support that the device is state-of-the-art relative to alternative treatments.
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Sara VanWyk, MPH, CCRP, RAC, MWC
Principal Regulatory Scientist, RQM+
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Original Message:
Sent: 28-Jan-2022 05:07
From: Carole Robin
Subject: similar devices
Hi Richard,
it seems you've completely understood the point. We have done what you wrote included similar devices to the SOTA as we can not use them independently.
All the best,
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Carole Robin
Director Regulatory Affairs
Lyon
France
Original Message:
Sent: 27-Jan-2022 11:06
From: Richard Vincins
Subject: similar devices
Bonjour Carole,
Sigh. There is so much mis-understanding around similar devices and equivalent devices - sadly hear this type of issue over and over. You should be able to use similar devices in assessment, but sadly often can only be a by-product of State of the Art (SOTA). For devices which are new or even legacy, there is a hierarchy which can be used, but again this is poorly understand by Notified Body reviewers. In some cases if there is little clinical data on the device, may require a clinical investigation or maybe can justify doing a Post Market Clinical Follow-up (PMCF). My only advice is you have to be very careful about using similar devices in clinical evaluation because too many reviewers just put this in the equivalency bucket.
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Richard Vincins ASQ-CQA, MTOPRA, RAC
Vice President Global Regulatory Affairs
Original Message:
Sent: 26-Jan-2022 07:49
From: Carole Robin
Subject: similar devices
Hi,
we are challenged by a NB regarding the similar devices used in the Clinical evaluation (see MEDDEV 2.7.1. rev 4). The reviewer is deemed to assess the similar devices to equivalence. We have to remove the similar devices used for the clinical evidence of a class III implantable. the data of the similar devices are to be used in the SOTA
In the MDCG 2020-6, on Clinical evaluation legacy devices, similar products are used in appendix III
"Suggested hierarchy of clinical evidence for confirmation of conformity with relevant GSPRs under the MDR" :
"Class III legacy devices and implantable legacy devices which are not well-established technologies should have sufficient clinical data as a minimum at level 4. Those devices which are well-established technologies may be able to confirm conformity with the relevant GSPRs via an evaluation of cumulative evidence from additional sources as listed below. Reliance solely on complaints and vigilance is not sufficient."
rank /level 6 similar device
Have you faced the same finding with similar devices used in clinical evaluation? When there are little clinical data on the device, how do you use data from other devices when equivalence can not be claimed? Then MDCG 2020-6 is on legacy devices, what about new devices?
Thx
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Carole Robin
Director Regulatory Affairs
Lyon
France
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