Testing a US device in Europe to prove Equivalence in a “head-to-head” Study

[pschnoor9]

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.

[Stijloor]

A Quick Bump!

Can someone help?

Thank you very much!!

[c.mitch]

Hello,

I answer you because I saw the quick bump! Perhaps other guys could give more information.
Clinical trials with MD that are not CE marked are regulated by article 15 of 93/42 EC directive. To do so, you shall build a technical file according to annex VII and ask the authorization to do clinical tests to the ethical commitee of the country where you want to do the tests.
The technical file should be easy to build, picking up data from your Fda clearance. The authorization should be easy or hard to obtain, depending on the "mood" of the authority.

[c.mitch]

Sorry there is a typo in my last post: annex VIII, not VII.

[PaulGr]

Hi,

From your post it is not clear if the 'identified US device' is your device or a competitors device. If it's the latter, you will have an issue with building the required file (see post of c.mitch) as key documents like the risk analysis and test report will not be directly available.

In that case I would suggest to check if you could proof equivalence based on intended use, technology, specifications from the manual and bench testing or other non-clinical testing.

Or, if you really need the clinical testing, consider running the tests in the US.

[Pads38]

clinical studies (not trials)

(ISO 14155)Clinical Investigation-
any designed and planned systematic study in human subjects undertaken to verify the safety and/or performance of a specific device.

Any studies that use humans are classed as Clinical Investigations. As c.mitch highlights these are regulated by annex VIII (and annex X). As part of that you will need to have your Clinical Investigation Plan authorised by the Ethics Committee of the institution involved and by the national Competent Authority (in the UK this is the MHRA). Detailed within your plan will need to be descriptions of equipment involved. The use of non-CE marked devices will need to be highlighted.

The authorisation to use such devices will depend upon the risks involved. If the device is marketed in the USA (with FDA clearance) this would give a high degree of confidence that the device would not represent significant unknown risk.

[pschnoor9]

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.