Classification of product for clinical trials

[Daliane]

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

 

[yodon]

On the surface, this sounds like fraudulent activity! You can't just "claim" a class. Classes are defined by the device meeting certain criteria. Look at the rules in the MDR, Annex VIII, Chapter III.

 

[shimonv]

I agree with Yodon.
The EU rep will register a product per your request. it's not their role really to determine its classification; It's the manufacturer's responsibility. And if the notified body has already determined that its class IIa you cannot ignore that and say "I have a class I registration through EU rep". It won't fly.

Shimon

 

[dgrainger]

Registration for class I devices is an administrative requirement under Article 14 of MDD - Individual Member states may review documentation (the UK didn't). So you could do this but it is likely to end badly!

 

[Raisin picker]

I actually have seen a case where a device was accepted to be class I by the competent authority of one EU country. The manufacturer still applied for a certificate for class IIa with a NB. I sadly didn't follow up on this, so I don't know the details. I just remember there being trouble because it was not made perfectly clear that the device sold (as class I) was not approved by that NB, and the company is still in business.

 

[Daliane]

Thanks all for your feedback.

The manufacturer informed me now that the clinical studies they want to conduct in Germany are not to proof performance, safety or intended use. (For conformity assessment they use the clinical trials conducted in their country).

So the clinical studies in Germany are only research studies. The KOL want to use this data to publish in journals.
Hence, as described above, to speed up the process they self-declare it as class I first to get CE and to enable the doctors to use it asap, otherwise it will take too long. In the same time they apply for CE mark to register the product as class IIa, and use the clinical data from their country (Taiwan).
Do you still think this is not a valid strategy? They are aware that research studies fall under MDR "other clinical studies" and need to fulfil the requirements listed there.

Appreciate your opinion.

Merry Christmas to everyone.

Best,
Daliane

 

[Ed Panek]

Are you consenting the patients with this information?

 

[indubioush]

So the clinical studies in Germany are only research studies.

It doesn't matter if this is considered an "other clinical investigation" per Article 82. If this is considered a medical device, you cannot change the classification, which is based on the regulation and device risk. Now, on the other hand, if this is not a medical device, or is not acting as one during this study, this might be a workaround for gathering data; however, in this case, it would not even be considered Class I because it would not be a device at all.

 

[monoj mon]

Hence, as described above, to speed up the process they self-declare it as class I first to get CE and to enable the doctors to use it asap, otherwise it will take too long.

What do they mean by this! Is regulatory compliance a joke to your client! The devices are classified based on the level of risk it possess. So, definitely the risk associated with a Class I device is different from the risk associated with the Class IIa device. Of course it takes time get approval just because the regulator needs evidence about the safety of the device prior to using it on patient. No one can just switch between device classification on their own just to fulfill their business strategy.

 

[Daliane]

I can totally follow and I am trying to convince them with the same "thoughts". Thank you all for your feedback!