Hello Anon,
Depending on the type of material, the functionality, and where used in the medical device, this could or could not be considered a significant change. Based on this is a Class III device and the injection port, I would say probably significant - at least a notification would probably be needed. Do look at your contract with the Notified Body as they typically describe what notifications and change notifications are required. Any change of material would be considered a design change, though depends on whether considered a significant change or not.
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Richard Vincins ASQ-CQA, MTOPRA, RAC
Principal Consultant
Oriel STAT A MATRIX - ENTERPRISE
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Original Message:
Sent: 10-Feb-2024 08:24
From: Anne LeBlanc
Subject: Medical Device GLP testing
Hello Anon
I'm not sure why "no submissions expected". Check your NB contract, but they generally do require notification of changes.
And yes, changing a material is a design change.
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Anne LeBlanc
United States
Original Message:
Sent: 08-Feb-2024 10:56
From: Anonymous Member
Subject: Medical Device GLP testing
This message was posted by a user wishing to remain anonymous
Hello,
I work for a small medical device company. We are working on a change control for a port on our class III non-implantable device. The change is a material change in an injection port - the rubber stopper is changing in material composition. The supplier has told us in their change control that this is a previously validated port that has been used historically in other medical devices. First, would this be considered a design change, even though it is similar and functions the same? Secondly, validations will include the ISO 10993 matrix of testing, but should these be GLP for updating our Technical Documentation (CE mark already obtained - no submissions expected).
Thanks for any help or advice anyone can give.