Classification of product for clinical trials

J0anne

Joanne
Hi all,

I am supporting my client during their clinical trial plan in Germany.

Their product is a class IIa product, but they have registered the product in Germany as class I to receive the CE-mark quicker in order to speed up the clinical trials.
The purpose of these trials are to gain data to publish in Journals. This data will not be used for conformity assessment.
Is this method valid?

But later, of course, they plan to place the product on the market as class IIa. But as I assume the data they gained under the device being registered as class I, I think this data is not valid anymore to support the conformity assessment of a class IIa product, is this correct? Do they have to repeat all studies for the conformity assessment or only partly?

The company is not in the EU. Their EU representative has agreed and registered the product as class I. The notified body has classified the product as class IIa as it is. So basically there is the proof that the device is safe and meets compliance.

But I am still sceptical about this process, register a class IIa product as class I to collect data for Journals. And later conduct trials again for the conformity assessment.

Can you please leave your opinion on that? The authority already told me this is not valid, but how come the EU representative made it to register the product as class I? I want to avoid my client to run into a big problem and loose time and money.

Thanks a lot

Regards
Daliane


I can't say your client isn't acting fraudulently as you haven't supplied enough detail but yes this is a valid method

People often use different regulatory pathways to market

For example I can bring a cream to market quickly as a cosmetic to raise some revenue

Then I can bring it to market as a medicine and later on as a medical device as well

It's all about the manufacturer's claims

But if your client is trying to speed things up, why on earth are they doing a clinical trial?
Clinical Trials aren't required for medical devices. They are certified safe and effective prior to marketing
 

monoj mon

Trusted Information Resource
I am not sure about your source of information for these statements!
but yes this is a valid method
How falsely classifying a device is a valid method! It is a strong violation of the regulations. This type of case is the perfect example why MDR is now trying to close the loopholes in the MDD.
Clinical Trials aren't required for medical devices. They are certified safe and effective prior to marketing
Well...
 
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Watchcat

Trusted Information Resource
I agree with Yodon.
The EU rep will register a product per your request. it's not their role really to determine its classification

To clarify, I think this was true under the MDD. My understanding is that under the MDR EU Reps will be held much more accountable. Not sure if it extends to being held accountable for registering an appropriate/inappropriate classification, but if not this, then anything else seems almost irrelevant.
 
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monoj mon

Trusted Information Resource
Not sure if it extends to being held accountable for registering an appropriate/inappropriate classification, but if not this, then anything seems almost irrelevant.
Yes, that is one concern. Hopefully EC will consider this.
 

moy_ahm

Registered
In the UK, the right approach would be to register the device with MHRA for clinical investigation as a non-CE marked device. And if they don't object, the clinical investigation can proceed.
It may be different in Germany but possibly not and worth checking directly.
The intended purpose defines the risk class so it cannot be class 1 without some justification.
 
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