Clinical Investigation - US/EU

#1
Dear all,

I have a question related to clinical investigations

I am wondering to which extent can Clinical Studies with medical devices carried out in the United States (by the same manufacturer) be used to substantiate the clinical evidence in Europe.

In other words, if a clinical study is carried out in the US following GCP and taking into consideration ISO 14155 requirements (and of course is appropriately designed and targets endpoints with clinical relevance and the results demonstrate the product has a clinical benefit), can this study be used as pivotal to support the obtention of the CE mark in Europe?

Also, if FDA advice is recieved related with clinical trial endpoints/design/etc (for instance following a pre-submission interaction) is this FDA feedback usually well accepted by the EU by notified bodies?

Many thanks in advance for your responses!!!

Best regards,
A.
 
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pziemlewicz

Involved In Discussions
#2
I'm sorry for being the bearer of bad news:
Different regions have very different requirements. Unless your study is specifically designed to incorporate requirements from both, one will not recognize the other. EU will not accept endpoints agreed to with FDA in Q-Sub. China, an extreme example, requires that studies be performed using Chinese nationals at a state-sponsored institution.

I wish it were easier, but no such luck.
 
#3
Hi pziemlewics,

many thanks for your response!

Definitely, this is bad news hahaha. It is difficult to understand that we may have to repeat a clinical investigation for the EU if, for instance, the clinical data obtained in the US is already relevant!

However, can you specify a little bit more how we can design a Clinical Investigation that covers both regions? For instance, if there is a Iso standard for a specific product (i.e. cardiac hear valves) and we design the CT according to the ISO requirements, do you thing that this Clinical Investigation will be accepted both by FDA and EU since the ISO is an international standard?

Also, are you aware of any regulatory document/guideline that specifies how to align EU and US clinical strategies?


Many thanks again for your time,
Best,
A
 

pziemlewicz

Involved In Discussions
#4
Unfortunately, because they are different regions, there is not one document to cover both. EU weighs heavily on MDR and International Standards, while FDA requirements are outlined in guidance documents (both general and specific to device type). While the clinical procedure might be the same, FDA has very specific tissue measurements, pathology photos, report formatting, and other requirements.

I'd recommend engaging a consultant, familiar with your device type and indications for use, to help you write a protocol.
 
#5
Hi pziemlewicz,

many thanks again for your response.

Then it is correct to interpret from your response that there could be a possibility on wirtting the protocol from the beggining considering both US and EU requirements?

would that be the appropiate way of solving this issue?

thanks again!
A
 

pziemlewicz

Involved In Discussions
#6
Then it is correct to interpret from your response that there could be a possibility on wirtting the protocol from the beggining considering both US and EU requirements?

A
Yes. This is often done in Human Factors using FDA Guidance and 62366 in the same protocols. It's very important to document the specific requirement origin, and have clear traceability.
 
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