Question

U.S. Clinical Evidence

  • 11 November 2022
  • 5 replies
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I received an anonymous question and wondered if I could get some help! 

If I have a device currently marketed in the US and I want to start marketing in the EU, is clinical evidence that comes only from the US acceptable for notified bodies or does clinical evidence also need to include EU and/or other parts of the world?

@joningib  @Keith Kallmes @BenB are you able to help?


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If they are wanting to bring their device to market in the EU, part of their clinical planning must consider the targeted population of the regions they are sending the device.

Without an appropriate cross section, the device will not/may not have considered all the necessary benefits and risks associated to the targeted population.

It could be that the studies they have done are comparable to the EU population, but there should always be a consideration when planning and assessing.

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@BenB do you know if the EU will accept justification of adequate representation (Eg., study was performed in the United States but consisted of study participants of European descent), or if there is a requirement that the study be performed in the EU?

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That I would have to defer I'm afraid, but I can certainly look into it.

When our studies were done we were already in the EU, all I understood was that our studies had to be representative of our target population.

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Agree with @BenB. I have heard that NBs tend to prefer data coming from the European market, especially if the device’s nature of performance can be impacted by race, genetics etc. However, it is not a specific requirement of the EU MDR itself.

A more important factor is whether the study was conducted as per ISO 14155:2020 or not.

The FDA requirements for GCP (21 CFR 812.28) are considered the standard for device GCP studies under the US FDA, but those requirements do not correspond to ISO 14155:2020. If the trial was not conducted as per 21CFR and ISO 14155:2020, the manufacturer will not be able to use the same data in Europe - because the NB’s in Europe look at ISO14155:2020, not 21CFR.

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Hi all, 

I have a different experience, usually in EU they don't really care where the data comes from, and you can use data from a US clinical trial for submitting to your NB in Europe.  

As Jon said they study must have been conducted as per ISO 14155:2020, and you need to justify your sample size.  Also the company must have a Clinical Evaluation Report (with its corresponding plan), according to the EU regulations. In the Clinical Evaluation Report you can also add market data from sales, adverse events and customer feedback in the US. If with all your data (literature, competitors, clinical trials, market experience), you can justify that your device is safe and effective that usually it’s enough for the NB. 

 

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