Whether the product is an accessory according to the MDR definition

Kyle Park

First of all, I am not a native speaker, so please understand that English expressions may be awkward.
I wonder if the product you handle is an accessory or a system.
The product is intended to expand blood vessels with a stent. Among the components of the product is a delivery (catheter) that delivers the stent to the blood vessel. Since the delivery here is not for medical purposes, is it an accessory? Maybe a system?
Even if you look up the definition of the term of MDR, it is difficult to distinguish.
NB's answer states that stents are defined as accessories according to the definition in MDR Article2.
Thank you for the clear answer from the experts.
Thank you in advance.


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Hello Kyle,
From a regulatory point - if the stent and catheter have the same classification it doesn't matter how you define the catheter; you have to treat them the same way.
I would think that if you provide the stent and catheter in the same sterile packaging - you have one device.



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Are the stent and catheter used alone or do you need something else to work with them, for example to open up a blood vessel? If so, can any such device be used or are there restrictions on what products your device/accessory will work? Is there clear guidance on this in your product's instructions for use?
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