Medical Devices in EU - OEM or OBL?

[fretcat]

hi,

I wonder what if a company in UE produces medical device class I (without measure and not sterile) and I will buy this medical device under my name and my graphic on labels? Who am I? OBL or OEM?
And what if this medical device is not the same as originally produced by the manufacuter? What if is it similar, but not the same? Who am I? OEM?
I wonder what documentation I should receive from the manufacturer who What documents should I receive from them when I am OEM and when I am OBL? Which are necessary for me to prepare technical documentation?
And what about clinical data?

Many thanks for help.

[MIREGMGR]

In Reply to Parent Post by fretcat

I wonder what if a company in UE produces medical device class I (without measure and not sterile) and I will buy this medical device under my name and my graphic on labels? Who am I? OBL or OEM?
And what if this medical device is not the same as originally produced by the manufacuter? What if is it similar, but not the same? Who am I? OEM?
I wonder what documentation I should receive from the manufacturer who What documents should I receive from them when I am OEM and when I am OBL? Which are necessary for me to prepare technical documentation?
And what about clinical data?

We need some basic information to understand your many rather open-ended questions.

What is the general nature of the product we're discussing? Where are you located, and where do you market?

If the medical device we're discussing "is not the same as originally produced by the manufacturer", or is similar but not the same, who modified it? What is your regulatory stance such that all of this matters to you?

Rather than asking us to explain the details of every possible product regulatory management question, it would be easier if you would tell us in some detail exactly what you are trying to do. Then we can answer a finite problem.