Selling an Unapproved Investigational Device for Clinical Studies

[tzuki]

I serve as a QA/RA manager in a medical device company .

We have a device which is CE marked and a device which hasn't been approved yet I would like to know if the device under development may be sold as an investigational device to an Investigator whoi is running a clinical studies of is own and the company ( device manufacturer) is not serving as a sponsor and therfore has no control or knowledge of the study protocol and study management. What are the european regulations in this case? What are the responsibilities of the manufacturer in this case?

 

[pkost]

the MDD covers clinical clinical investigations in annex X section 2.

Although there doesn't appear to be any specific requirement for the manufacturer to control the study, I would suggest it would be very difficult to demonstrate to the competent authority when you apply for permission to carry out the investigation that the method is appropriate.

You are the manufacturer and therefore you are best qualified to say what is not known about the device and what needs to be tested. If you don't control the investigation you are unlikely to get the information that you require from it.

I apologise if I am wrong, but it appears to me that you are trying to shoe horn a device onto the the market so that it is available for this particular user...this is not an appropriate use of a clinical investigation. You must have a clear set of aims and objectives to start an investigation for your own purposes - not another's. (see the quote below)

The objectives of clinical investigation are:
— to verify that, under normal conditions of use, the performance of the
devices conform to those referred to in Section 3 of Annex I, and
— to determine any undesirable side-effects, under normal conditions of
use, and assess whether they constitute risks when weighed against
the intended performance of the device.

 

[MIREGMGR]

Under US FDA rules, an Investigational Device may be provided to an investigator prior to the device achieving normal marketing clearance, for use in a study of some medical issue other than the safety and effectiveness of the device itself. There are of course safeguards, i.e. the IDE process, and rules for the pre-approval and responsible supervision of the investigational process.

Under both US and EC rules, a device may be used in clinical trials to establish that it is safe and effective. This is the process described in MDD Annex X.

Under the MDD's Article 15, a device may be used in a study of a similar nature to the US FDA "Investigational Device" process.

I'm not sure of the meaning of the question as to "responsibilities of the manufacturer". A device used in an Article 15 study does not meet the MDD definition of "placement on the market", but I don't know of any reason why the courts would not regard the maker as nonetheless responsible in the event that harm was determined to have resulted from the device's use.