Timescales for Changing Medical Device Labeling

C

cjr978

#1
We are looking at a potential relocation of our local subsiduary that acts as our EU authorized representative.

Can anyone point me at information on the timescales for transitioning labelling on existing stock to the new address in the event of such a change?

thanks
 
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sreenu927

Quite Involved in Discussions
#2
Hi,

It depends on the criticality of the change.

If it is location of ECREP only, then you can use the existing inventory for US.
If EU, two options : Along with the product you send a letter-to-file or customer notification regarding the change in location of ECREP, if the inventory is more;
else scrap the inventory; use the new released label.

If ECREP itself - then it more critical than the location. So you need to immediately revise the labels and use it. Existing label inventory to be scrapped according to your disposition process.

There is/are no specific timelines to update the label changes. However, if any change that is substantial/significant, then it has to be informed to appropriate regulatory authorities by conducting due diligence (Use these guidance docs: Deciding when to submit a 510(k) for an existing device-US, Substantial Change reporting -EU; Significant changes reporting for high risk devices- Health Canada).

Depending on the significance, as a manufacturer you can either do
- right away you can update and use the labels
- a phase-out running change with a justification through a letter-to-file/Memo-to-file or customer notification

Hope this helps!

Regards,
Sreenu
 
Last edited:
C

cjr978

#3
Hi,

It depends on the criticality of the change.

If it is location of ECREP only, then you can use the existing inventory for US.
If EU, two options : Along with the product you send a letter-to-file or customer notification regarding the change in location of ECREP, if the inventory is more;
else scrap the inventory; use the new released label.
Thanks - your response was quite helpful.

Its purely an address change rather than than anything else. Do you have a link to any guidance that was issued to the effect that you describe?

many thanks
Chris
 
R

Rolande Hall

#4
I would like to suggest that you ask your notified body for guidance, they will be able to tell you what they require.
:cfingers:
 

sreenu927

Quite Involved in Discussions
#5
See attached spreadsheet of what constitutes a significant change as per EU, US, Canada and Singapore (which I had prepared for our Company sometime back).
The EU guidance may be revised. pls check in the NBMED Guidance docs for the latest ones.

For your case, I would suggest:
- If you have any SOP for significant changes reporting, perform analysis whether it is a significant change or not
- based on the evaluation you need to notify to appropriate stake holders such as regulatory agencies, distributors, customers, suppliers, etc.
- the address change falls under non-significant change, as it doesn;t affect the product quality and safety and no additional risks raised, so there is no need to report to the authority. You can document this justification and file it in Technical File or DHF
- To inform customers and other stakeholders, you can either use a memo-to-file or any form associated with your procedure that is best suitable for this purpose.

Regards,
Sreenu
 

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