Impact of Distribution Center Site Change on Product Registrations

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William_55401

Question. We are a medical device mfr planning a change in EU distribution sites. There is no planned change to the manufacturing site. Does anyone have insight as to the impact of this change on Technical Files or rest of the world product registrations? My first reaction is to say no impact as distribution does not typically show up in Tech Files, EU labeling, or in product registration documents. Please share your thoughts. Thank you for your help.
 
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MIREGMGR

I assume your Forum-location is the responsible manufacturer's location, i.e. USA?

If so, then EU device registration is handled by your Authorized Representative, and you can leave to their expertise whether the change you want to make has any significance.

My guess is that it won't, i.e. I agree with your analysis in full, but they can make the call based on more complete knowledge of the details.
 
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William_55401

Thank you MRI. This is very helpful. I have been reading your posts and was hoping you would check in on this one.
 
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