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Significant change notice for outsourced warehouse

#1
Hi All,

I am new to medical device Regulatory Affairs and trying to get to grips with Quality management System Significant Change Notifications. I have referred to the NBOG for Best practices for reporting Design and Quality Management system changes.

My change is in relation to an outsourced warehouse and whether I need to submit a significant change notice to the notified body to add storage of finished products to an already existing outsourced warehouse.

Just wondering if anyone can shed any light
Thanks!
 

JoshuaFroud

Involved In Discussions
#2
Hi and welcome Learner!

When it comes to significant change it is usually better to take a more cautious approach. If you are unsure, it is generally safer and has little impact (assuming your NB does not charge you for submitting the change notice) to submit a change notice for something you did not need to rather than not submit something you should. Also, your NB is hopefully fairly easy to communicate with, I have submitted proposed changed to my NB, with supporting evidence and justification, previously asking if they would consider it a significant change. They have always been helpful in responding.

When determining significant change the key questions to ask are; is there any possible impact on product Quality or Risk Management? If so look further into this change and is the impact positive or negative, is it a new risk or amended risk? They are the kind of question you will want to consider.

A quick web search throws up some guidance documents, one following; http://www.meddev.info/_documents/R2_5_2-2_rev7.pdf


If you are already using an outsourced warehouse to store similar items in a similar manner, then with justification the change may not be significant.
 

craiglab

Involved In Discussions
#3
...and if your NB is BSI then this 2015 presentation might help https://www.bsigroup.com/meddev/Loc...l/Reporting Changes to your Notified Body.pdf
Also, if your NB wants change notifications submitted via a form, like BSI does, then by all means go through the exercise of completing it and use that to drive your conclusion to send it or not. Keep that on file to support your decision. I agree with JoshuaFroud's conclusion about similar/similar. Use risk-based thinking.
 
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