Hi all.
I am seeking information on when a change to a class III device is considered substantial, and therefore requires notification to my notified body.
I have a product that has changes in some specifications for lot release, but not performance specifications. The specifications in question are important because they dictate our ability to meet performance specs at time of use and shelf life.
The lot release specifications are being relaxed from where they currently are. I suspect this will likely need to be sent as a notice of change to my notified body, but I cannot find any guidance documents defining when a change is substantial and notification is required. Is anyone aware of documents that offer guidance in this decision?
Thanks!
I am seeking information on when a change to a class III device is considered substantial, and therefore requires notification to my notified body.
I have a product that has changes in some specifications for lot release, but not performance specifications. The specifications in question are important because they dictate our ability to meet performance specs at time of use and shelf life.
The lot release specifications are being relaxed from where they currently are. I suspect this will likely need to be sent as a notice of change to my notified body, but I cannot find any guidance documents defining when a change is substantial and notification is required. Is anyone aware of documents that offer guidance in this decision?
Thanks!