Impact of changing manufacturer post clinical investigation

[rosh]

Hi everybody, I have some queries regarding the impact of changing manufacturer post clinical investigation.
Let’s say there are 2 manufactures, manufacturer A and manufacturer B.
For “series 0” production we used manufacturer A and did all our V&V testing and used those series 0 products for clinical investigation (CI) and will be using the data generated from the CI to submit to the notified body.
However, for the production of devices for market release, we might change to manufacturer B.

• What would be the impact of changing manufacturer?
• Do we have to repeat all the V&V testing (biocomp, sterilisation, cleaning etc).

Regards,
Rosh

 

[planB]

Rosh.

the answer is: it depends.

You would have to repeat all V&V testing where you assess the change from manufacturer A to B having a significant impact on the already existing test results. In case your assessment comes to the conclusion that the changes associated with the manufacturer change are indeed significant, this might trigger a notified-body change notification/application on its own: you could end up with two notified-body submissions in case you decided to submit data related to manufacturer A at this point in time.

HTH,

 

[indubioush]

Even if you determine that repeating V&V is not required, you will have to notify your notified body about the change. Minimally, you will have to qualify the new facility to ensure it is equivalent to your old facility. This may include repeating process validation.

 

[rosh]

@planB and @ indubioush thanks for your replies.

rosh