Hi,
What sort of changes in design/process/documentation indicate a notification to the NB?
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Your obligation to inform the NB under :
1. Product changes - If the change would effect conformity with the essential requirements and / or the conditions prescribed for the intended use of the device.
a. change introduces a new device or new hazard which has not been previously addressed.
b. change adversly affects the risk associated with existing hazards
c. change alters the details on intended use na d/ or compliance with the essential requirement given in the device master record submitted to the NB.
d. Change means that the device will have different end user or be used in a different manner or for a different purpose.
e. Change means that the clinical data from the original device is not sufficient to confirm conformity of the changed device with the required characteristecs and performance.
2. Changes to Quality system - The matters that are considered when deciding whether or not particular changes are substantial include the following.
a. Change alters the manufacturing technology.
b. Change affects product conformity route.
c. Change affects the continued compliance of the quality system with the relevant harmonized standards against which it has been approved.
d. Change affects the arrangement for ensuring continued compliance with the requirements of the directiv. Ex. verification , validation etc...
e. change require that the manufacturing processes and controls are re-validated.
The above are termed as Substantial changes. Your notification to the NB must include :
1. Brief description of the modifications compared to the approved design / device or the approved quality system.
2. Reason for changes / modifications.
3. In the case of design / device changes, a statement on the relevance to the compliance with the essential requirements of the directive.