Good day Anon,
A Research Use Only (RUO) device is exactly that - for research use only. This means it is not used in patients, on patients, or with patients - even reporting diagnostic testing results to patients. An IVD medical device which is for RUO would be testing human specimens with no traceability or identification to the actual patient and certainly no reporting back to the patient. An RUO would be used for confirming if an IVD medical device test could properly identify a marker or disease condition - which is not specific to the patient. These are often used in pre-analytical testing or development work of an IVD assay.
So no, there is no pathway for CE Marking an RUO product because as others have stated this is outside the IVDR regulation 2017/746.
To answer your question, yes you can sell CE Marked IVD medical devices as RUO products as organisations like drug-manufacturers, universities, or other research companies might find this interesting. Though once CE Marked an IVD medical device can be sold as a finished medical device and does not need a designation of RUO. It is up to the user whether they would use this for reporting results to patients or doing their own research.
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Richard Vincins ASQ-CQA, MTOPRA, RAC
Principal Strategy Consultant
NAMSA
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Original Message:
Sent: 25-Mar-2024 23:47
From: Anonymous Member
Subject: CE-Mark for RUO Device
This message was posted by a user wishing to remain anonymous
The product you mentioned sounds like it would be an IVD if the device was to be used for clinical diagnostic purposes. For an IVD under IVDR, if you comply with the IVDR and if relevant pass a notified body conformity assessment, you can obtain a CE Mark. But you mentioned seeking a CE Mark for an RUO product. The IVDR is for IVDs, RUO products are out of scope of the IVDR. Therefore a CE Mark for an RUO product per the IVDR is not possible. However, you could potentially have two versions of the product, one being a CE Marked IVD and the other being a non-CE Marked RUO; for each product there would need to be its own SKU number (creating more internal work), appropriate labeling, etc.
Original Message:
Sent: 25-Mar-2024 06:19
From: Anonymous Member
Subject: CE-Mark for RUO Device
This message was posted by a user wishing to remain anonymous
Hello RAPS community,
I'm reaching out to gather your thoughts and advice on a regulatory matter. Our company is in the process of obtaining CE marking for our reader and assay cartridge. Upon reviewing the device as a whole (reader + cartridge), it falls under the IVDR. However, the company intends to market it as Research Use Only (RUO), possibly to circumvent IVDR compliance.
I'm uncertain if there exists a regulatory pathway specifically for CE marking of RUO devices. My company is very interested in selling RUO products that are CE-marked.
If we do obtain the CE mark under IVDR, can we still sell the device as RUO?
Your insights and guidance on this matter would be immensely valuable.
Thank you!