Change to Outer Packaging Material/Supplier - Sterile, Class IV Device

Jen C

Involved In Discussions
Our device is CE marked, sterile, class IV. The packaging has undergone validation under ISTA 3A-elongated. The device is packaged in an inner pouch, which is then placed in a box; several boxes are packaged in an outer shipping box for distribution.

We want to add a new supplier for the product box (the one in which the pouch is placed). The supplier is approved through our quality system and the box has the same specifications as the original box.

Would a new packaging validation be required, or can this be simply addressed with a risk analysis since the materials and dimensions of the box are the same?

I am unsure of whether this meets the definition of a "substantial change" under NB-MED/2.5.2/Rec2 as it's a change in a validated system, but not a "true" change since the new box should be identical to the old.

Thanks for any input!


Super Moderator
Re: Change to Outer Packaging Material/Supplier

A Quick Bump!

Can someone help?

Thank you very much!


Quite Involved in Discussions
Hi Jen C,

Upon the assessment of risk analysis or impact analysis based on the EU MEDDEV or FDA's Guidance on when to submit a new 510(k) for a change to an existing device or Health Canada's guidance document on significant change, you document the analysis.
As it is Class IV, so discuss with your Notified Body about your (preliminary) assessment ensuring the change does not affect the performance of the product. And let them assess and provide you feedback, whether they are ok to document the change or whether it requires any notification to them.



Trusted Information Resource
I think you are confusing your regulations: you are referecning EU documents, but there is no such thing as a Class IV medical device in Europe


Quite Involved in Discussions
My mistake..thanks pkost.
I assumed it as Class IV per Health Canada.

What I meant is - Class IV in Canada would be a Class III (Medical device) per EU regulations, so contact the EU Notified Body as you have already obtained CE Marking.

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