Do I need a design inputs outputs?


Right so my company buys from a supplier as OEM. We are branching our product to have a new brand addition.
Do we need to do a Design inputs/outputs/ Design change etc.? For this.
Or can we just introduce Labels and IFUs that have the new brand logo but say they are manufactured at our site?
All these products are Annex III IVD.

Or can someone inform me the documentation requirements we would need to add a new brand addition to our QMS

Thank you

Ed Panek

QA RA Small Med Dev Company
Super Moderator
I would lean on the OEM directing you to define your requirements. In the USA an FDA registration might be needed but just ask the OEM precisely what they need. You are probably considered a high risk supplier so they would audit you as well to any requirements. The audit will also cover your specific requirements.


Super Moderator
First off, what device class is the product? If Class I and exempt from design controls, the point is mostly moot.

You say you apply your brand logo. That *sounds* like you're framing yourself as the LEGAL manufacturer. Will you be, for example, taking complaints regarding the product?
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