Regulatory Open Forum

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

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 

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

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

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 

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

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.

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

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 

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

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

Hi Ella,

Is there anything that can be said about how the device facilitates a medical procedure, which does have a clinical benefit? It may also help to go back to the definition of a medical device in the MDR, which is very broad and provides wording you may reference to when you place your medical device in the context of its use. The medical benefit may be defined on the level of state of the art: describe what is the common treatment for the condition, with benefits taken from high-level review articles, then show how your device fits into that treatment. A clinical benefit can also be "a positive impact on patient management or public health".

Kind regards,

Wiebe

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

Hello Ella,

It does sound like maybe they are only looking for wording in the clinical evaluation - which does not surprise me.  These Notified Body reviewers are using checklists which a line item says, "Ensure the information specifies how indirect clinical benefits and risks are identified."  So they are looking for those exact wording :( sadly.  Without seeing the whole information, I think the wording you proposed might help address their point, though it is always 50/50 these days with reviewers.  Without them clearly detailing what is the issue, hard to get into their thought process.

Hi Ella,

Is there anything that can be said about how the device facilitates a medical procedure, which does have a clinical benefit? It may also help to go back to the definition of a medical device in the MDR, which is very broad and provides wording you may reference to when you place your medical device in the context of its use. The medical benefit may be defined on the level of state of the art: describe what is the common treatment for the condition, with benefits taken from high-level review articles, then show how your device fits into that treatment. A clinical benefit can also be "a positive impact on patient management or public health".

Kind regards,

Wiebe

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

Hi Ella,

Is there anything that can be said about how the device facilitates a medical procedure, which does have a clinical benefit? It may also help to go back to the definition of a medical device in the MDR, which is very broad and provides wording you may reference to when you place your medical device in the context of its use. The medical benefit may be defined on the level of state of the art: describe what is the common treatment for the condition, with benefits taken from high-level review articles, then show how your device fits into that treatment. A clinical benefit can also be "a positive impact on patient management or public health".

Kind regards,

Wiebe

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

Hi Wiebe

Thank you for your reply. 

We know the direct benefits of the device, the problem is with the inderect one :)

Ella

Hi Ella,

Is there anything that can be said about how the device facilitates a medical procedure, which does have a clinical benefit? It may also help to go back to the definition of a medical device in the MDR, which is very broad and provides wording you may reference to when you place your medical device in the context of its use. The medical benefit may be defined on the level of state of the art: describe what is the common treatment for the condition, with benefits taken from high-level review articles, then show how your device fits into that treatment. A clinical benefit can also be "a positive impact on patient management or public health".

Kind regards,

Wiebe

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