Pre-market vs post-market clinical investigation

[VI Me]

We have a device already FDA certified in the USA through 510k and we are submitting the device to EU MDR.

For our EU MDR submission our pivotal clinical evidence is a clinical investigation that has been conducted on the device after it was launched for sale in the US.

We plan to share an interim report as our primary clinical evidence, and then continue the study into the post-market period as PMCF for long term follow up once the device is certified in the EU.

My specific question is: how do we present this clinical investigation in the CER. Is it a pre-market clinical investigation, because the data is being used to support this initial submission for EU and the device is not yet EU certified (but the study is not being conducted within the EU itself), or is it PMCF because the device is already available in the US where the study is taking place?

 

[shimonv]

IMO - It's a clinical investigation data from the US; don't think you need other descriptions.
The EU reviewer will look at it for what it is; the fact that you got FDA approval without it is irrelevant.

 

[yodon]

This might be a follow-on for @shimonv (because I don't know) but would there need to be rationale justifying the data is relevant for the EU population (since not done in the EU)?

 

[Al_Z1]

According to MDR it is possible to conduct clinical investigation outside EU member states, but for me it is unclear, is it necessary to do it as multi-centered with at least one centre in EU, cause appropriate paragraph in MDR could be read differently. Concerning demography data I agree with @yodon, it might require justification.

 

[VI Me]

Thanks @shimonv so when it comes to specifying the route for demonstration of conformity, should we be presenting it as the clinical investigation route? my colleagues feel that if we present it as a clinical investigation and not as just PMCF then we open ourselves up to further questions due to the requirements of clinical investigations under MDR, they see this as purely a PMCF study because it is technically post-market in the region it is being conducted.

I personally think the MDR application will not be successful if we do not present it as pre-market clinical investigation, since clinical investigation is (mostly) required for new devices being certified under MDR.

@yodon thanks, I agree we will likely need a justification for the applicability to the EU population, we have had this question on other files in the past. I don't know if we need to build it into the CER or just have the justification on file in case of questions.

 

[dgrainger]

The clinical data could be considered under scientific literature of an equivalent device.

It doesn't appear to meet the requirements of Article 62 which would require a member state to authorise the study (it would also need to be in that member state plus any other 3rd country). So might be rejected by the NB.

It doesn't appear to be a PMCF either, this is defined in Article 74:
"Where a clinical investigation is to be conducted to further assess, within the scope of its intended purpose, a device which already bears the CE marking in accordance with Article 20(1), (‘PMCF investigation’),..."

 

[VI Me]

Thanks @dgrainger it isn't an equivalent device, it is the specific device in question, and it is not published clinical literature either, so I'm not sure those routes would apply.

I feel like this study falls into a very grey area under MDR but this route must be taken by other manufacturers because it is obviously a lot quicker and easier to get devices into the US under the FDA vs EU MDR, and easier to get clinical studies set up in the US vs Europe, so many manufacturers must get the device established in the US first in order to obtain data for submission to the EU.