Thank you Richard!
The device deals with prostatic hyperplasia and it indeed does not have any indirect benefits, but, unfortunately, it has some indirect risks, as most of the invasive devices. And according to MDCG 2020-5 it looks like this is what they actually looking for. But this doesn't help to naswer their question.... As we supplied the risk management and we supplied the clinical studies which show also the safety of the device.
Based on other comments it really looks like they are looking for key words rather than actual data, since their comments are copy paste from the MDCG. Still, I am not sure how to respond to this, as just stating there are no indirect benefits seems not sufficient because the MDCG refers to the associated risks.
So, maybe stating something like- there are no indirect benefits, the indirect risks were addressd in the clinical sudies presented in the CER, therefore no need for clinical evudence for the indirect clinical benefits? How does this sound?
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Ella Sheiman
Haifa
Israel
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Original Message:
Sent: 27-Oct-2023 08:23
From: Richard Vincins
Subject: indirect clinical benefit
Hello Ella,
The first comment I would make is this highly depends on the medical device because some do not have any indirect clinical benefit. Would it be a good thing to maybe say there is "no indirect clinical benefit"? Maybe; though I believe a good reviewer would understand if there was not any indirect clinical benefit. So the first determination would be if there was any indirect clinical benefit for the device. If the device does have indirect clinical benefit, this also is helpful to elicit in a clinical evaluation though I would challenge "proving" this as part of the clinical evaluation process. The EU and Notified Bodies are continually putting hurdles and barriers in place for organisations to overcome and this is another point exactly putting in barriers.
While pointing out an indirect clinical benefit for a device is again helpful, making a company go through proving through clinical evidence this exists (or does not exist) is worrisome and burdensome. This is especially true is the device has been on the market, well characterised, and its intended purposes is well known. To answer your question giving a couple simple examples for indirect clinical benefit may be a wound healing product which primary clinical benefit is providing a good environment for healing with an indirect benefit of preventing contamination (you could argue those are both primary clinical benefits, but just an example). Another one may be a planning software for placement of an implant say for dental with an indirect benefit of avoiding sensitive locations, nerves, or other obstructions during the surgery. Again, it really depends on the device and MDCG 2020-5 an 2020-6 does give some examples, but I think you may need to discuss your specific device to get some meaningful information - if even applicable.
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Richard Vincins ASQ-CQA, MTOPRA, RAC
Vice President Global Regulatory Affairs
Original Message:
Sent: 27-Oct-2023 06:39
From: Ella Sheiman
Subject: indirect clinical benefit
Hi Olga
Thank you very much for your clarification questions.
Indeed I am talking about medical device and the comments are from a NB reviewing our Clinical Evaluation Plan.
Thank you
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Ella Sheiman
Haifa
Israel
Original Message:
Sent: 27-Oct-2023 04:50
From: Olga Peycheva
Subject: indirect clinical benefit
Hello Ella,
You need to give us a bit more information. From what I understand so far this is a medical device application in EU. It is not clear if the question is coming from a regulatory agency as part of clinical investigation submission or from a NB as part of CE marking submission.
If it is part of clinical investigation related question you should have information about risk / benefit in the risk assessment plan. If it is coming from a NB I am sure some of the colleagues in the forum will be able to advice.
Thank you,
Olga
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Olga Peycheva
Regulatory and Study Start Up Specialist
Solutions OP Ltd
https://solutionsop.co.uk/
United Kingdom
Original Message:
Sent: 26-Oct-2023 02:30
From: Ella Sheiman
Subject: indirect clinical benefit
Hello collegues
How do you deal with the requirement to define the level of clinical evidence required to demonstrate an indirect clinical benefit (e.g. based risk assessment and evaluation of short, medium and long term clinical risks) in your CEP and CER? The examples for this in the MDCG 2020-6 are very general and I am not sure I understand it corrrectly.
I know that it should be based on a specific product and its risk assessment but Iwould be thankfull for some examples to help me with identifiying it and addressing it in the CEP and CER.
Thank you
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Ella Sheiman
Haifa
Israel
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