Hello Anon,
The points Arthur raised are really good ... I would also add any medical device (or perceived medical device) used with a human subject in Europe or placed on the market needs to have Ethics Committee approval and clinical trial protocol. Even in your first question if the device is to be used to assist another device, if there is any type of "interaction" with the patient or the healthcare professional is using your device to diagnosis, monitor, or provide therapy, as in conjunction with the other device, need to be included in the protocol. Without knowing exactly the type of device, how its being used, how its being used with the other device, or intended purpose, all of this would be hard to say.
As far as importing, products can be imported as long as they are properly labelled as Arthur indicated. Make sure to use caution about how the device can be used or making it "unusable" so it can not be used with a patient. Again, if a product is sold and placed on the market without a CE Mark and used with a human subject, there needs to be Ethics Committee approval in place and clinical investigation. If being used as a sample for the customers to see the device, ensure properly labelled and no use of device could be made with a patient.
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Richard Vincins RAC
Vice President Global Regulatory Affairs
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Original Message:
Sent: 24-Aug-2020 20:26
From: Arthur Brandwood
Subject: EU evaluation of non-CE marked product
Hi ANon, You are asking two separate questions here. I'll take them in turn:
Can the device be supplied for evaluation
The following applies in most markets. If you label your device clearly - "Sample for Evaluation only: Not approved for supply in <Market> NOT FOR CLINICAL USE" then you can supply the sample. but you do need to be clear that the user can't try the device out on an actual patient.
Can the device be used in a clinical trial
The only way you can do this if the device is not CE marked is to include the device explicitly as an experimental item within the trial protocol, and have the protocol reviewed by a competent authority in the country where the trial is being undertaken. Effectively you are conducting a trial of the device along with whatever else is being evaluated within the trial. Then it is legal to supply the device as an Investigational Use Only item. It needs to be labeled as such. Again, these principles apply in most markets.
Hope this all helps
Arthur
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Arthur Brandwood PhD FRAPS
Director and Principal Consultant
Brandwood CKC
Sydney, Australia
Arthur.brandwood@brandwoodckc.com
www.brandwoodckc.com
Original Message:
Sent: 24-Aug-2020 15:31
From: Anonymous Member
Subject: EU evaluation of non-CE marked product
This message was posted by a user wishing to remain anonymous
Hello all,
My US organization has an FDA cleared class II device (I believe it would be a class IIb in the EU). It is not CE marked. I have two questions.
Potential customers residing in the EU want to use the device in clinical studies of other investigational products. I don't think the device can be used in a clinical study within the EU since it is not itself CE-marked. This study is not an evaluation or investigation of my company's device. The customer only wants to use it as a tool in a study they are conducting.
Secondly, some potential customers residing in the EU want to evaluate the device for potential purchase once the CE mark is obtained. So, they would need access to the non-CE marked device within the EU in order to do this.
My questions are:
1. Can a non-CE marked device be used in the EU to assist with a clinical study of something else?
2. Is there any way to allow a customer to import a non-CE marked device into the EU so they can see if it is something they would be interested in purchasing down the road?
Thanks to anyone who may have some insight with this. If there are any guidances/regulations you can point me to, I would appreciate it.