Using clinical trial safety data for evidence for CE marking

[CPhelan]

Hello,
We are heading into a first in human safety clinical trial with our product in coming months. We are going to hold introductory discussions with our notified body in coming weeks to discuss a pathway.

I wanted to ask has anyone experience in using safety data for evidence for CE marking?

 

[Marc]

A quick "Bump". Thanks in advance to anyone who can help.

 

[Watchcat]

Marc, this really belongs under medical devices, EU regulations, I think? If you agree, you might want to move it over there.

In the meantime...

Every CE marked medical device must be supported by a clinical evaluation, which means that all device regulatory professionals who have gotten a medical device CE marked have experience in using safety data for evidence for CE marking. The data may be from trials reported in the literature; or from trials the company sponsored. The depth and breadth of that experience undoubtedly varies.

 

[CPhelan]

Marc, this really belongs under medical devices, EU regulations, I think? If you agree, you might want to move it over there.

In the meantime...

Every CE marked medical device must be supported by a clinical evaluation, which means that all device regulatory professionals who have gotten a medical device CE marked have experience in using safety data for evidence for CE marking. The data may be from trials reported in the literature; or from trials the company sponsored. The depth and breadth of that experience undoubtedly varies.

Thank you for the response. We have a number of clinical trials lined up. Our first clinical trial will be used as a load/dose escalation to determine the safest volume to put into patients. We will not be getting any efficacy data from this study as this will be determined from our next clinical trials.

We are going to speak to our notified body on this issue but is it acceptable to apply for CE marking using safety data alone without efficacy data?

Also thank you Marc for the bump.

 

[Watchcat]

Really, the data that you need should be identified in your risk analysis. No idea what your notified body will tell you, but I'm dying to hear.

What makes you think you need to conduct a safety trial?

Also would be very interested to know how you got an NB to give you the time of day, given their (lack of) bandwidth. Is it designated under the MDR/IVDR?

 

[CPhelan]

A safety trial is what has been recommended for our product after speaking with our KOL surgeon as we are first company to complete a FIH clinical trial in this country so this is to provide more comfort to the local health authority.

From what I have read safety and/or efficacy data can be used for evidence for CE marking.

Our RA SME has recently left the company and while I am not filling in his role I am just asking a question in a community subject matter experts on the subject I'm not too familiar with. I've been with the company for a number of years and while I can go on about what I have completed as well as the company over the past three years I appreciate you looking out for my my professional career...

 

[Ronen E]

I don't think that you are likely to get the EC certificate in this case without clinical efficacy data, but obviously I don't have the whole picture and what really matters is what your NB will say about that. I think that in the meantime you should follow the clinical investigation path under the MDR. Please feel welcome to send me a PM if you want me to get more involved.
Good luck!

 

[SKM.Sunil]

Thank you for the response. We have a number of clinical trials lined up. Our first clinical trial will be used as a load/dose escalation to determine the safest volume to put into patients. We will not be getting any efficacy data from this study as this will be determined from our next clinical trials.

We are going to speak to our notified body on this issue but is it acceptable to apply for CE marking using safety data alone without efficacy data?

Also thank you Marc for the bump.

I am not sure, why you are going with a dose escalation study. you can always refer a similar or predicate device and published literature for the same and meanwhile you can go for a efficacy/performance study or comparative study for the device (here still you can valuate the safety). If you are abiding to ISO 14155 and RM ISO 14971, You are at very good position to get CE certificate, if your study and TD yield good results.

with only safety data by trial, its prove that your device is not completely a performing device to go for market/patient use or even CE. The path you are going, I believe you have to wait till your all trials get over and then apply for CE/FDA or any other

 

[Parul Chansoria]

For CE marking both safety and performance data are required. Using the safety data alone will not help meeting the General Safety and performance Requirements (GSPR). For demonstrating equivalence the level of clinical evidence should be based on the similarity with the equivalent device. Further, between MDR and MDD the approach for clinical evaluation and hence the evaluation of clinical data is aligned. For CE marking there is a direct correlation between the intended use and the clinical data. You would therefore need pivotal data for the device performance.