Morning,
If the product regardless of designation calling it a demo, sample, or trial product, if this is a medical device that can be used as a medical device for an intended purpose, then it is always considered a medical device.
There are no specific regulatory guidelines or rules for labeling Demo (demonstration) devices, however, there are requirements around providing devices that are not approved for use in the specific country, i.e. FDA has regulations around not selling or distributing non-approved, non-cleared devices.
This then leads to the question, again regardless of calling it a demo or sample, can the product (a medical device) be used, meaning is it fully functional, and is the device approved/cleared? Most regulations are quite clear that non-approved/non-cleared devices can not be used with/on/in patients without IRB/Ethics Committee approval. If you are providing a Demo device, first it should be clearly labelled and second should theoretically be non-functioning. As an example, we had an electronic device attached to catheter we would show to potential doctors in-house and at trade shows - it was a non-cleared device in the US - the device had no power supply associated, i.e. no battery so it could not be turned on. We had a device at our trade show we could turn on and show to physicians, but it could not really be used. Depending on the type of device you are talking about, there are ways to provide Demo devices that are non-functioning and certainly items like Demo implants would be fairly safe as doubt a physician would implant a Demo unit haha.
Just make sure the Demo kits are clearly labeled as not approved, not for human use, etc., there is some wording out there can be used such as wording from FDA information. Also important is make sure these Demo kits are "controlled" just like any other inventory item so you know how many are being sold, where they are going, and if there is reconciliation needed for them.
------------------------------
Richard Vincins RAC
Vice President Global Regulatory Affairs
------------------------------
Original Message:
Sent: 14-Aug-2019 10:38
From: Anonymous Member
Subject: Qestion for DEMO kit for devices
This message was posted by a user wishing to remain anonymous
Hello RAPS members,
I have a questions regarding Demo kit for devices. Two questions:
1. Are demonstration devices considered non-medical devices? From my perspective, demo devices are also medical devices but wanted to confirm.
2. Are you aware of an EU or US regulatory guidance on labeling for Demo devices?
Thank you.