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OTS (Off-the-shelf) Medical Device Accessories - Camera

#1
Hello,
I'm trying to understand if an Off-the-shelf, general purpose (not medical device specific) accessory is classifiable as accessory to a medical device or if it can be considered a supporting platform (like generic laptops of smartphones).
The scenario is the following:
The company produces a sw which runs on a generic computer. The SW is a medical device. In order to provide certain functions, the sw needs a camera. It can be any off-the-shelf camera. The company makes sure the sw works correctly with the recommended camera(s) through appropriate validation. The company does not provide the camera, the user purchases it separately.

Is the camera an accessory to a medical device or a component? If so, should the company provide the camera rather than giving the task to the user?

Thanks!

Matteo Gubellini
 

Ronen E

Problem Solver
Staff member
Super Moderator
#2
Hello,
I'm trying to understand if an Off-the-shelf, general purpose (not medical device specific) accessory is classifiable as accessory to a medical device or if it can be considered a supporting platform (like generic laptops of smartphones).
The scenario is the following:
The company produces a sw which runs on a generic computer. The SW is a medical device. In order to provide certain functions, the sw needs a camera. It can be any off-the-shelf camera. The company makes sure the sw works correctly with the recommended camera(s) through appropriate validation. The company does not provide the camera, the user purchases it separately.

Is the camera an accessory to a medical device or a component? If so, should the company provide the camera rather than giving the task to the user?

Thanks!

Matteo Gubellini
The MDR definition begins with:
‘accessory for a medical device’ means an article which, whilst not being itself a medical device, is intended by its manufacturer to be used together with one or several particular medical device(s)...
(My emphasis)

If the camera's manufacturer doesn't explicitly designate their camera for use with your SW (or arguably, that particular type of SW), it doesn't meet that definition.

Even if it did, this wouldn't have created an obligation for you to supply it.
 
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