We will ship from Europe to USA a configurable medical device (IVD) where one of its components, a display, has a CE mark as Medical device (MDR) therefore labeled with a UDI and MD symbol. This electronic component does not have clearance in USA as Medical device. Should we relabel the display to remove UDI, MD symbol and CE mark?. We think this label can mislead our users in USA since the MD symbol and UDI are not applicable for the USA market. The UDI is placed for the complete configurable device in another component of the product.
Removing the MD symbol and UDI information is probably not necessary since the MD symbol is not widely known yet in the healthcare industry, including the US. Though you are probably right, the inclusion of the MD symbol, does designate the device, product, or component as a medical device, so the product would need to meet all regulatory requirements. The UDI is a more neutral aspect which does not really indicate any compliance, certification, or regulation being followed - this can be seen as tracing a device. In fact, when I work currently on clinical trials we already incorporate UDI into the device labelling for identification and traceability which is helpful.
I would definitely recommend removing the CE Mark because this has been commonly construed as a "quality mark" or acceptance mark for the European market as well as many other markets. Even in the United States they often view the CE Mark as an "approval" so the inclusion of a CE Mark on the label could be construed by the importation or user as something else, including some clearance or approval in the U.S. However, if the CE Mark is for something else like Low Voltage Directive or something, then maybe it is ok.
For me, the most important condition in your scenario is if the configurable medical device has this display but the "system" is not cleared or approved in the United States, the component should have another indication. This may include clear labelling for Investigational Use Only (IUO) if part of a clinical trial, Research Use Only (RUO), or not for human use at all - such as a marketing or product to be viewed not according to indications for use. Or even potentially it is NOT a medical device, but just a component used with the IVD, so the labelling should be reflective of that point, i.e. no MD symbol. Any medical device, component, accessory, or otherwise needs to be properly cleared or approved in the U.S., if the component is part of the "system" and used with, on, or for a patient, this may need to meet proper compliance requirements. It sounds like there are a few things with this component you might want to seek some further advice on regulatory status, labelling, and how the "medical device" is presented from a compliance perspective.
What is the reason to have that component as medical device in the EU and not considered Medical device in the US? If you can provide rationale for that, I do not see reason to remove EU MDR related compliance information. On the other hand it needs to be clear which UDI is relevant for placing of a product on the US market. If you have two AIDC, on on the component and one that represents complete configurable device, how do you make that clear to the user.
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