Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Hello,

We have a device that is not CE marked but has been approved as part of Drug Co X's clinical trial to be performed in France, Germany, and Italy.    How do we get this device through customs without a CE mark?  Do we have to petition these governments as the manufacturer, does Drug Co X do this, or do the doctors performing the clinical trial need to do this?

Thanks.

Unfortunately, unlike the US (where an investigational device can be included in a drug IND), there is no streamlined mechanism to accomplish the same in the EU. Devices used in the drug study must either be CE-marked OR be approved for investigation use via CTAs to all applicable CAs. This is course makes it quite a challenge to operationalize such a study in Europe, though it has been done. Alternatively, depending on what the device is, one could try to find a CE-marked equivalent.

Regardless, best of luck and feel free to send me a direct message if you'd like to discuss in more detail.

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Jonathan Amaya-Hodges
Director, Technical Services
Sharon MA
United States
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Original Message:
Sent: 15-Sep-2023 10:33
From: Anonymous Member
Subject: EU Clinical Trial with non-CE marked Device

This message was posted by a user wishing to remain anonymous

Hello,

We have a device that is not CE marked but has been approved as part of Drug Co X's clinical trial to be performed in France, Germany, and Italy.    How do we get this device through customs without a CE mark?  Do we have to petition these governments as the manufacturer, does Drug Co X do this, or do the doctors performing the clinical trial need to do this?

Thanks.

Dear Anon,

If you have approval to start your drug clinical trial without having been requested for a separate device CTA for the non-CE Marked (unapproved) device, consider yourself fortunate.  Recent experience has had several Competent authorities request a separate CTA and protocol for the non-CE marked device in addition to the CTA for the Medicinal Product.

Regardless, the device that has not be CE Marked must be considered, and labeled/identified as, an investigational product, with the approved CTA as the reference.  This should enable you to get it through customs.

------------------------------
Lee Leichter RAC
President
Fort Denaud FL
United States
------------------------------

Original Message:
Sent: 15-Sep-2023 10:33
From: Anonymous Member
Subject: EU Clinical Trial with non-CE marked Device

This message was posted by a user wishing to remain anonymous

Hello,

We have a device that is not CE marked but has been approved as part of Drug Co X's clinical trial to be performed in France, Germany, and Italy.    How do we get this device through customs without a CE mark?  Do we have to petition these governments as the manufacturer, does Drug Co X do this, or do the doctors performing the clinical trial need to do this?

Thanks.

Dear Anon,

If you have approval to start your drug clinical trial without having been requested for a separate device CTA for the non-CE Marked (unapproved) device, consider yourself fortunate.  Recent experience has had several Competent authorities request a separate CTA and protocol for the non-CE marked device in addition to the CTA for the Medicinal Product.

Regardless, the device that has not be CE Marked must be considered, and labeled/identified as, an investigational product, with the approved CTA as the reference.  This should enable you to get it through customs.

------------------------------
Lee Leichter RAC
President
Fort Denaud FL
United States
------------------------------

Original Message:
Sent: 15-Sep-2023 10:33
From: Anonymous Member
Subject: EU Clinical Trial with non-CE marked Device

This message was posted by a user wishing to remain anonymous

Hello,

We have a device that is not CE marked but has been approved as part of Drug Co X's clinical trial to be performed in France, Germany, and Italy.    How do we get this device through customs without a CE mark?  Do we have to petition these governments as the manufacturer, does Drug Co X do this, or do the doctors performing the clinical trial need to do this?

Thanks.

Wow! This is quite interesting: Exposing EU citizens to a device that is not CE-marked, while the device related risks appear not to be covered... Or am I missing something here? 

Apart from this interesting issue, if the device is stopped at customs, they will ask about the status of that device to the legal person based at the address where the devices will be delivered. If you can show the CTA identifying the device, this would probably work. Carefully decide who will be the first to receive these devices and make sure it is clear from the labeling that these devices are only intended for clinical trial XYZ. Otherwise, you may still be considered placing devices on the Union Market for further distribution and use. 

------------------------------
Ronald Boumans
MDR Expert
Super PRRC
Netherlands
------------------------------

Original Message:
Sent: 15-Sep-2023 10:33
From: Anonymous Member
Subject: EU Clinical Trial with non-CE marked Device

This message was posted by a user wishing to remain anonymous

Hello,

We have a device that is not CE marked but has been approved as part of Drug Co X's clinical trial to be performed in France, Germany, and Italy.    How do we get this device through customs without a CE mark?  Do we have to petition these governments as the manufacturer, does Drug Co X do this, or do the doctors performing the clinical trial need to do this?

Thanks.

Hello,

As Jonathan explained you cannot have medical device without CE mark used in drug clinical trial. If the device is not CE marked then it is considered investigational and you have to submit it as such for approval. Alternative is to use similar CE marked device.

There is a tendency lately among the regulatory authorities that they do not inform you if you have not submitted something correctly. The rational behind this is that it is sponsor responsibility to check the regulations, make sure they submit all necessary documents and obtain all required approvals. I think companies can no longer relay that the competent authorities will tell them what is missing. 

Make sure you check before you use it in clinical trial.

Have a great week,

Olga

------------------------------
Olga Peycheva
Regulatory and Study Start Up Specialist
Solutions OP Ltd
olga.peycheva@solutionsop.co.uk
United Kingdom
------------------------------

Original Message:
Sent: 15-Sep-2023 10:33
From: Anonymous Member
Subject: EU Clinical Trial with non-CE marked Device

This message was posted by a user wishing to remain anonymous

Hello,

We have a device that is not CE marked but has been approved as part of Drug Co X's clinical trial to be performed in France, Germany, and Italy.    How do we get this device through customs without a CE mark?  Do we have to petition these governments as the manufacturer, does Drug Co X do this, or do the doctors performing the clinical trial need to do this?

Thanks.

hi there, 

as already pointed out below, for the use of devices (IVDs/MD) within clinical trial in EU with an impact on patient management there are 3 options:

• the device is CE-marked and you are using it acc. it's intended purpose -> no further action is needed
• the device is not CE-marked
  • the device is considered investigational: a separate application for authorisation for the use of the device is needed to the device CA (Annex XIV), you need approval of the involved NCAs before the start of the study.
  • the device is considered as an in-house device: only possible if all requirements of article 5.5 are fulfilled (of which a very important one is that such tests can only be conducted by facilities recognised as 'health institutions' established in the EU)

------------------------------
Anne Paulussen
Sr RA Expert
Geel
Belgium
------------------------------

Original Message:
Sent: 15-Sep-2023 10:33
From: Anonymous Member
Subject: EU Clinical Trial with non-CE marked Device

This message was posted by a user wishing to remain anonymous

Hello,

We have a device that is not CE marked but has been approved as part of Drug Co X's clinical trial to be performed in France, Germany, and Italy.    How do we get this device through customs without a CE mark?  Do we have to petition these governments as the manufacturer, does Drug Co X do this, or do the doctors performing the clinical trial need to do this?

Thanks.

Hi Anon,

as others in the thread pointed out getting the device through customs should be feasible with a declaration as an investigational devicen and backing of the respective CTA covering it.

However, as also already pointed out: Usually the approval procedures for medicinal product (drug) and medical device trials in Europe are independent from each other. It might therefore make sense to take a more detailed look at the current CTA and to ensure that it really covers the device and the authorities were clear on that - especially if you would later like to use the resulting clinical data to CE-mark the device.

Best regards

Christoph

Best regards, Christoph

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Christoph Kiesselbach
Reutlingen
Germany
------------------------------

Original Message:
Sent: 15-Sep-2023 10:33
From: Anonymous Member
Subject: EU Clinical Trial with non-CE marked Device

This message was posted by a user wishing to remain anonymous

Hello,

We have a device that is not CE marked but has been approved as part of Drug Co X's clinical trial to be performed in France, Germany, and Italy.    How do we get this device through customs without a CE mark?  Do we have to petition these governments as the manufacturer, does Drug Co X do this, or do the doctors performing the clinical trial need to do this?

Thanks.