Pre-market vs post-market clinical investigation

Aliken

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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?
I don't see any problem with including a US clinical study in the CER for the MDR submission; after all, this is the only clinical supportive data you have. By the way, I believe the study could be used (assuming it is performed according to international clinical study standards) even if there is no FDA approval. This assumes that the EU patient population is comparable to the US population, as the experts in the group already wrote. You asked if it is a pre-market clinical investigation (regarding the EU) or a PMCF because the device is already available in the US, where the study took place. You don't need to use the term "pre-market," as @shimonv wrote, and that's not even relevant. What is relevant is to explain that these are your clinical supportive data for the EU market and that the device, intended use, intended users, and targeted population are the same. Once the device is certified and marketed in the EU, you can "continue" the study into the post-market period as PMCF (it would be called PMCF study but not because the device is already available in the US) for long-term follow-up, although I would try to avoid the term "continue." You usually don't continue the study unless it is temporarily discontinued. Rather, you will start a new (PMCF) study based on the new PMS plan, new PMCF plan and new clinical protocol. Good luck!
 
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