Regulatory Open Forum

We have a class I device. It is 510k exempt. We will be showing them at both USA and European tradeshows. The device is small and cannot be marked with DEMO USE ONLY without interfering with the use of the device. I have two questions:

1. I cannot find any guidances from the FDA or Europe regarding demo unit labeling. Are there any? Do I need to directly mark these products?
2.  We have not added this part to our FDA Establishment listing yet because we aren't yet selling them. Can we still show them at the trade shows and simply not take orders?

For EU rules, see the Blue Guide. There is a section about trade fairs, exhibitions and demonstrations.

https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=OJ:C:2022:247:TOC

There is no specific US guidance on demo labeling of exempt devices still in development. Sometimes trade shows publish their own rules about appropriate labeling. Previous posts on the subject have described typical labels or signage, segregating such items to a different part of the booth, and making sure all the staff know not to do pre-orders.