OEM vs OBL Classification in the CE Certification

Mor628

Involved In Discussions
#1
Hi guys!

We, an OBL company with CE cert buy Luer Lock Caps for IV Therapy from our OEM also with a CE cert.

However, our (OBL CE) cert declares this product as a Class Is medical device, and the (OEM CE) declares the same product as a Class IIa medical device.

Should I now amend our (OBL) CE cert to follow the OEM and declare as Class IIa?

To prepare a Declaration of Conformity, do I follow the OBL-CE or the OEM-CE?

Please advice!

Appreciate any feedback or comments! Thank you
 
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shimonv

Trusted Information Resource
#2
Hi Mor628,
It seems to me that what is classified as class IIa is the whole administration set manufactured by the OEM.The Luer lock cap is a component or perhaps an accessory to an administration set. If it's an accessory, class Is seems reasonable, but you need to check it further.

Anyways, if you need to amend your Declaration of Conformity it should follow the OEM-CE because it depends on it.

BR,
Shimon
 

rob73

looking for answers
#3
Mor628
As OBL you are responsible for placing on the market, you need to go through the classification process yourself to ensure that it is correct. Just because they declare it class 1s or II doe not mean they are right, or that is applicable to what you are doing. Always best to cover your own backside, as no-one is going to do it for you.
 

Mor628

Involved In Discussions
#4
Great idea Shimon! I will check with them, that's probably why its classified as a Class IIa device.

Thanks Rob, that's most likely what we will be doing. Just wanted to be sure :)
 
V

Vlad_M

#6
Hello everyone!

Does OBL really will become obsolete soon? As far as I know - NB will just pay more attention to an OBL's TF and agreement.

So, the OBL - will be doable in future, it just will require slightly more time to prepare a documentation.

Please correct me if I'm wrong in my assumptions...
 
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