Hi - you already have the answer in the question:
"general requirements concerning records (820.180) and complaint files (820.198)." To find out which records are required, do a word search on "record" in 21 CFR 820. Also, 21 CFR 803 and 806 will apply. Other than that, you can comply with whichever requirements of 21 CFR 820 or ISO 13485 that you believe will reduce your commercial risks to an acceptable level.
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Roger Gray
VP Quality and Regulatory
Donawa Lifescience Consulting
Rome, Italy
+39 06 578 2665
rgray@donawa.com------------------------------
Original Message:
Sent: 02-Jun-2017 14:25
From: Anonymous Member
Subject: GMP exempt devices, Class I
This message was posted by a user wishing to remain anonymous
I've never had a device is that is GMP Exempt. What are the requirements for Class I devices that are GMP exempt? For example, Product Code JRG is a Class 1, 510(k) Exempt, and GMP Exempt. The regulation states, "Note: This device is also exempted from the GMP regulation, except for general requirements concerning records (820.180) and complaint files (820.198), as long as the device is not labeled or otherwise represented as sterile."
What would be the appropriate QMS documentation for a device under this Product Code?