Industrial OBL Practices

[Aliasanonymous]

I don't think I can find answers anywhere except from industry experts like you guys.. so here's my question:

I have been told that it is industrial practice for big companies to buy in products and label it as their own (OBL) and obtain market approval for the product (CE/FDA). Does it mean that they have to purchase the product from this manufacturer for life, or is it also practice to be able to switch manufacturers, without having to re-obtain approval? Assuming, of course, that the product mentioned has the same specification, both manufacturers have FDA/CE approval of the manufactured product, and the OBL has access to all technical documentations.

I'm having doubts because as much as it is not economical to be tied down to a manufacturer ("supplier" of the product), it seems pretty uncontrolled otherwise.

I am not referring to any specific products, just a general industrial point.

 

[somashekar]

Does it mean that they have to purchase the product from this manufacturer for life, or is it also practice to be able to switch manufacturers, without having to re-obtain approval?

Yes, you purchase the product from the manufacturer for life time of the product. You can continue your purchasing of products in the OBL route as long as you both agree to be in your business, however that manufacturer has to continue to have the valid CE and you have the valid OBL CE. Even when you decide to discontinue your business association, all the previous CE marked products are still your products and your agreement about support from the OEM manufacturer for any regulatory and technical requirements must be continued to be established to the lifetime of the products.
Such business association you can have with many OEM manufacturers concurrently. Each of them being a valid OBL CE.

 

[Aliasanonymous]

Somashekar,

Thank you for your reply.
If I got that right, it means that an OBL CE is tagged to a manufacturer's CE for each product and if one decides to stop using A's products and switch to B's, a new OBL CE is needed?

 

[somashekar]

Somashekar,

Thank you for your reply.
If I got that right, it means that an OBL CE is tagged to a manufacturer's CE for each product and if one decides to stop using A's products and switch to B's, a new OBL CE is needed?

you said that right ~~~

 

[Aliasanonymous]

I thought so too. Just needed a confirmation because my boss thinks otherwise. He probably looked too much at the business point of view.

Thank you so much!
Now I need to convince him I was right....

 

[rob73]

there are several threads on OBL here

https://elsmar.com/Forums/search.php?searchid=4619261