Hello Anon,
It would not be advisable to label a device as both Research Use Only (RUO) and for diagnostic purposes - as Erik said this would be very problematic. Most regulatory agencies around the world would have an issue with this approach. Just because there is some statement in the Instructions for Use (IFU) or on a screen does not forego a user using the device for either or purpose .. when they should not. Indeed the instrument if used for research - not for human use or reporting human results - this would typically be the first status of a device. Then once the device is approved in the regulatory region, it would then be labelled according to the regulatory requirements.
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Richard Vincins ASQ-CQA, MTOPRA, RAC
Vice President Global Regulatory Affairs
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Original Message:
Sent: 04-Jul-2023 02:32
From: Erik Vollebregt
Subject: Label options for Dx and RUO dual use medical device
In the Union this kind of quantum state labeling would be problematic, because the device cannot be both at the same time. It would be possible to apply the CE mark for a Dx to e.g. an RUO instrument that has already been installed and has been validated to meet clinical performance requirements for CE mark. I suppose that it would be possible to use a CE marked Dx instrument for RUO applications. To avoid off label use these RUO applications would really need to be research only and have nothing to do with patient sample testing for clinical results.
In the Union (which is EU plus Iceland, Norway, Liechtenstein and Turkey) you would be dealing with the IVDR (Regulation (EU) 2017/746) for this.
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Erik Vollebregt
Partner
Amsterdam
Netherlands
Original Message:
Sent: 02-Jul-2023 00:23
From: Anonymous Member
Subject: Label options for Dx and RUO dual use medical device
This message was posted by a user wishing to remain anonymous
I would greatly appreciate your thoughts about what labeling options exist for a dual use (RUO and Dx) medical device instrument for the analysis of blood samples.
It'll be RUO by default and clearly presented as RUO in the user interactive screen to set up the test and also RUO descriptions in the research results. However, the instrument's software can be Dx enabled with clear Dx use and Dx in the test report.
Are there example of similar devices I can use for reference?
Can both RUO and Dx labels be affixed to the instrument since the screen and report will indicate the enabled use for each test?
Or does it has to be labeled RUO and then relabeled Dx following the Dx enablement?
What labeling options can one considered?
How labeling regulations for dual use instruments may be different in USA Vs EU Vs Asia Pacific and other territories?