Hello:
For clarification purposes, when you say clinician training, can you elaborate on how this is conducted? For example, are you executing this training and then bringing all the models back with you, or are these models sent out to physicians for them to train to in their office setting and left with them upon the completion of training? Can you also elaborate on what you mean by "place them on the market"?
If you think a phone call would be easier, please feel free to email me directly, and we can set up a time to have a discussion on the specific purposes for these items and any considerations that should be accounted for from a RA/Quality perspective.
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Andrea Pilon Artman, MS, CQE
President & Principal Consultant
SpectRA Compliance, LLC
Frederick, MD
USA
andrea.artman@spectracompliancellc.com------------------------------
Original Message:
Sent: 14-Jun-2019 07:24
From: Anonymous Member
Subject: cured polymers
This message was posted by a user wishing to remain anonymous
Hello community,
I wonder what it is your take on 3D printed items (which basically are polymerized resins) or silicon models that are used for clinicians training. They are not medical device so they don't fall under medical devices regs (neither FDA nor MDR in Europe).
However, what are the regulatory requirements to place them into the market? I guess TSCA (USA) and REACH (Europe) apply. What else? Is needed a CE Mark as a general product?
I guess there may be some risks involved on the biocompatibility of these products, for example whether the polymerization is complete, whether they raise some contact safety concerns for the users (i.e., the clinicians).
Thanks for your insights.