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Change Notification Requirements for class 1 devices

Lemko

Registered
#1
Not sure where to post this. Newer to a company that is subcontractor of class1 medical carts. Coming from a class II/III final manufacturer I'm used to 30 day notifications and annual change reports. I've had different responses when I ask if changes being made have been communicated to customers. Mostly a "not a significant" change so no notification is required answer. What I'm unable to find is what kind of change notification does a class I device required? Does an annual report of changes need to be made by customers so all changes should be communicated? Or should my company even be trying to evaluate and should anything more than a correction be sent to the customer for them to evaluate?

Example, a label on an internal component was changed from an old physical address to the current website. I consider this something the customer should be made aware of-but when I asked I was told there is no impact to function so communication isn't required.

If someone can let me know what general requirements are for post-market changes to a class 1 device are, I can evaluate what the customer may want to know and help me decide when I internally emphasize the need for communication to the customer.
 
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Lemko

Registered
#2
There is a lot of guidance on how to evaluate changes as significant or not significant, however I am struggling to find what do to with changes (either significant or not significant) for class 1 devices. Seems like its more of a 'have them available if someone asks'. Then the question would be should the subcontractor have the list of changes, or does the final company (the customer) need to have the list. Thanks in advance.
 
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