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Testing a US device in Europe to prove Equivalence in a “head-to-head” Study
We have identified a US device as our predicate for a medical device being produced in Europe. In order to prove equivalence in a “head-to-head” study, we would like to bring some of these devices to Europe for testing.
Is there anyone with knowledge or experience regarding clinical studies (not trials) that involve the use in Europe of a non-CE marked device from the US? These devices will not be put on the market in Europe and will remain the property of our company. Also, the agreement with the study participants will follow GCP, including the requirement for return of the device at the end of the study.
Is it appropriate to use the 510k clearance of the US device as a basis for a “safe to use” claim?
Any advice or guidance is appreciated.
We have identified a US device as our predicate for a medical device being produced in Europe. In order to prove equivalence in a “head-to-head” study, we would like to bring some of these devices to Europe for testing.
Is there anyone with knowledge or experience regarding clinical studies (not trials) that involve the use in Europe of a non-CE marked device from the US? These devices will not be put on the market in Europe and will remain the property of our company. Also, the agreement with the study participants will follow GCP, including the requirement for return of the device at the end of the study.
Is it appropriate to use the 510k clearance of the US device as a basis for a “safe to use” claim?
Any advice or guidance is appreciated.
Thank you to all three respondents - the information is very helpful. The device is a competitor device, so a technical file is not possible; we have written our rationale for allowing this study, but it seems the biggest concern is the possibility that we will be perceived to be "placing this (non CE marked) device on the market". We have stipulated that we will control access to the devices, but no approval yet.