It is certainly not a In Vitro Diagnostic (IVD) medical device - the brief description provided would not fall under the definition of an IVD according to the Regulation. As for a medical device, may or may not be - this really depends on the claims, intended use, intended purpose, etc. or even if you want to have the device in the medical device arena. There are quite a factors involved in determining whether a system like this would be a medical device; you would want to look at the definition in the regulations closely and then the intended purpose of the product. Then determine whether this falls under definition of a medical device. The U.S. FDA has a mechanism for determining device or not a device, but not as straightforward in the EU.
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Richard Vincins RAC
Vice President Global Regulatory Affairs
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Original Message:
Sent: 13-Jan-2020 20:36
From: Weirong Mo
Subject: Is hospital logistic robots an IVD medical device?
A customer hospital wants to customize a type of logistic robot (and the software) for transporting sterilized medical instruments and/or specimen for lab use within the hospital zone. Can this type of logistic robot be determined as an IVD medical device?
If this is not a medical device, then what kind of regulation do these robots comply with?
Thanks.
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Weirong Mo
San Jose CA
United States
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