Research Medical Device EU - Requirements and Regulations

[tebusse]

Greetings!

Does anyone know what the EU requirements are for exporting a device (non-IVD) that will be used for research? Is the device required to be part of a clinical trial? What would the requirements be for an academic institution to use the device?

Any assistance would be most helpful.

Regards, Tonia

 

[sagai]

Even though this product is not subject to any medical device directive, I strongly believe that you should affix CE mark (unless it is kind of specialized software) and as such you should comply with the directive that pertains to that CE mark.
We might get closer if you could share a bit more of the intended use of this device.
Hope this helps.
Cheers

 

[FoGia]

The question is quite unclear. What do you mean by 'research'? Is it a prototype for pre-clinical testing or do you want to use it on humans? And if it's the latter, will it be used in the EU or elsewhere?

 

[tebusse]

The device is available for commercial use in the U.S. and is not a prototype. We would intend the device to be used on humans and in research probably using phantoms.

We currently have non-commercial units that are intended for investigational use only.

The device itself is intended to detect the presence of radiopharmaceutical that remains near the injection site in an organ or body tissue as part of nuclear medicine procedures.

 

[FoGia]

You're familiar with investigational devices, that's the only option aside CE marking or humanitary exemptions to get it to use on humans.

 

[dgrainger]

Is the intended purpose that you mention for detection and prevention of extravasation injuries?
This could be considered to be a medical purpose and the product would be a device.

 

[tebusse]

Is the intended purpose that you mention for detection and prevention of extravasation injuries?
This could be considered to be a medical purpose and the product would be a device.

We don't claim that the intended purpose is to detect and prevent infiltration or extravasation. We only claim to detect the presence of radiotracer at the injection site. The device is not for diagnostic or therapeutic use.

The device is considered a medical device in the U.S. - nuclear uptake probe would be the generic name.

For the research to be conducted in the EU, the device would be part of a study, but not the focus of it. The device would be used as a tool to help determine the study endpoints. Given this factor, does Article 15 and Annex VIII of the MDD apply? Annex X of the MDD wouldn't apply IMO because the study isn't assessing safety/efficacy of the device.

 

[tebusse]

You're familiar with investigational devices, that's the only option aside CE marking or humanitary exemptions to get it to use on humans.

This particular research study would be in the EU. The device wouldn't be the focus of the study, but a tool for assisting the primary endpoints of the study. Given that the study isn't determining the device's safety or efficacy, I would think Annex X of the MDD would not apply. Additionally, I'm wondering about Article 15 and Annex VIII of the MDD as well.

 

[FoGia]

It seems to me that your question boils down to know if your device is considered a medical device in the EU. Contact a notified body to ask them the question.

If it does, Annex X applies - as it does for all medical devices.
The way you describe the situation your device is not an investigational device, even if it's used in the frame of a clinical investigation. If CE marking of your device is not an option you will need to notifiy the competent authorities that you're going to use the device in the clinical investigation.

 

[tebusse]

It seems to me that your question boils down to know if your device is considered a medical device in the EU. Contact a notified body to ask them the question.

If it does, Annex X applies - as it does for all medical devices.
The way you describe the situation your device is not an investigational device, even if it's used in the frame of a clinical investigation. If CE marking of your device is not an option you will need to notifiy the competent authorities that you're going to use the device in the clinical investigation.

We know the device is medical device and have taken the necessary steps for CE marking by preparing a technical and clinical evaluation report. Currently, the device does not bear the mark. We have commercial and non-commercial (e.g. investigational) devices in our inventory.

What I'm really attempting to understand are the requirements for exporting a non-CE marked device into the EU for a research study in which our device will be used as a tool with the purpose of the study not being related to safety or efficacy of the device. The device we would export would be a non-commercial device.