820.200 Servicing Procedure - Our system (because there is an API involved) is classified as Class 3

#1
Hello medical device family!

I have a question regarding section 820.200 - Servicing.

Background: Part of our device "system" includes an analyzer, manufactured in Europe, and by itself is a Class 1 Device. Our system (because there is an API involved) is classified as Class 3. The analyzers are a private label for our brand. The manufacturer states that per their classification and European guidelines they are required not to provide servicing procedures, and that it is essentially the responsibility of the user (per their IFU and Handbook). They have provided me with "recommendations" of what should be changed internally at certain intervals, and that a technician should be performing these replacements.

Since there are recommended "tests" that are to be performed, and recommended replacements that should occur at certain intervals, it makes sense to me that we should have a servicing procedure.

I am just curious if there are any others out there who have had experience with this type of scenario and how they have generated their servicing procedures. We do have a 3rd party that will handle our servicing if need be, but I need to develop the protocol first. I am not sure really how to even begin.

What do servicing procedures typically entail? Are they specific to more complex medical devices like CT scanners / MRIs, etc.?

:thanx:
 
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