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Clinical Trial to sell in the EU - Necessary or Not?

R

Rich Bass

#1
Hi all,

My company have a class III unique product, currently sold around 10,000 products in the USA. With this sort of PMS data am I still required to do a clinical study to sell in the EU?

Hoping someone can help
 
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yodon

Staff member
Super Moderator
#2
Not an expert but I want to be involved in this conversation.

I don't believe you have provided sufficient information to make a call. Sales does not equate to PMS data.

And I think there's probably general confusion over clinical evidence (data) -v- clinical studies. I believe (and hopefully someone will correct me if I'm wrong) that the intent of MEDDEV 2.7/1 revision 4 (guideline on clinical evaluations) is to get manufacturers to collect sufficient data to be able to continue to assert that their device is sufficiently safe and effective. If you do not have such data (and you can't support the assertion through other means such as literature review), you may well need to conduct a clinical study to get sufficient data.

The MDR defines a rather complex (IMO) system of vigilance, PMS, clinical evaluation and it all is expected to tie into risk management, usability, etc.
 

Marcelo

Inactive Registered Visitor
#3
You need to perform a clinical evaluation to verify of current clinical data are enough to show compliance with specific essential requirements, as all devices require a clinica evaluation. A clinical investigation (clinical trial) is a way to gather clinical data.

For implantable and class III devices, a clinical investigation is also always required, unless there a duly substantiated justification on why not to perform it.

With the above, one way to not perform a clinical investigation is to show in your clinical evaluation that current clinical data is enough to show compliance with the specific essential requirements, clinical risk are known and controlled, side effects are known and their occurrence is also known and under the estimates, and thus the benefit/risk profile is known and the benefit overweights the risk.

This can be done if your clinical evaluation is done correctly and also your current clinical data is good. Unfortunately, the fact that the device has been in a market for some time does not automatically implies that the clinical data is good.

For one, manufacturers usually do not systematically gather the data they should in a way that can be considered scientifically and statistically valid (for example, data on benefits). Another problem is to have data only from the US but no from EU.

So, you may be able to skip a clinical investigation, but you also may not.

Finally, NBs (which have been historically accepting bogus justifications for years) are being pushed to not accept justifications anymore unless they are really really strong with scientifically proven clinical data, so this is another possible problem.
 
R

Rich Bass

#4
Thank you for your comments.

For some additional information, we have had no complaints and no adverse events from the 10,000 or so products sold. We have not completed a post market clinical follow up of any kind but plan to send a questionnaire to customers which focuses in on some of the claims. There is some literature available on the product but not too much (approximately 12 good trials have been done on this product type).

The CER could be made to highlight all claims and risks but i still don't know if this will be enough. The cost to get an NB in to review and then fail is not one our company can sacrifice especially if we have to do a trial after?

Any advice is very welcome.
 

Marcelo

Inactive Registered Visitor
#5
For some additional information, we have had no complaints and no adverse events from the 10,000 or so products sold.
Not to be picky, but lack of complaints does not mean that problems do not exist, even more so because it's known that problems are underreported (there's an estimation that only 3-4 % of problems are reported to MAUDE, and MAUD is known to very VERY underreported).

We have not completed a post market clinical follow up of any kind but plan to send a questionnaire to customers which focuses in on some of the claims.
You would need to calculate how much response you would need to have a statistically and scientifically response data. Also, I would take care with using questionaries only, besides they being difficult to get answers.

There is some literature available on the product but not too much (approximately 12 good trials have been done on this product type).
The fact that trials have been done on the product type does not mean much, as only data from equivalent devices can be used to show compliance with ERs (you can use data from similar devices for other means, thought).

The CER could be made to highlight all claims and risks but i still don't know if this will be enough.
It's really impossible to say anything without clear information, that's why I've been giving only generic guidance. It's also impossible to know how the NB would react.

The cost to get an NB in to review and then fail is not one our company can sacrifice especially if we have to do a trial after?
Well, the only solution in this case would be to do a clinical trial before, but this is obviously more costly. I still think that a good clinical evaluation with scientifically sound data could be accepted (but again, this depends on the device).
 
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