How to obtain Own Brand Label (OBL) CE Marking?

NicoleinFlorida

Involved In Discussions
#1
Hello cove,

We are a start-up medical device company located in the U.S. We are considering to introduce a new product as OBL. The OEM of this product has obtained CE mark. I am wondering whether this is feasible and how long it may take us to obtain the CE. This is a Class IIa product.

Comparing with the OBL marking, will it be easier for us to obtain 510k approval? We have two products that have been approved by the FDA.

Thank you for all your valuable inputs.
 
#2
OBL/OEM was never fully recognised in the directive and in recent years the traditional OBL route has been evolving into what is now referred to as virtual manufacturer.

In the past you could request a small amount of documentation from the OEM and submit it along with a technical agreement and the OEM's CE mark only to receive a certificate a month or so later. More recently notified bodies are treating the application as if the OEM doesn't exist. You can still submit their documentation, but the review is thorough and likely to flag issues that were missed by the OEM notified body which will then have to be addressed.

Timescales are heavily dependent on
  • quality of OEM documentation
  • NB leadtime (they are overworked at the moment)
  • device classification
 

RobertvanBoxtel

Involved In Discussions
#3
Based on increased competent authority scrutiny on OBL manufacturers, more and more NB's are moving towards "virtual" manufacturers.
Expectations: Have the complete dossier and the processes in place to maintain it.
Are OEM's willing to provide you with this information?
 

nozzle

Starting to get Involved
#4
I've attended three seminars recently where the notified bodies were leading EU based companies away from virtual manufacturing towards distributed by. There are pros and cons for this but for smaller size businesses it removes the need to hold the full technical file and the unannounced audit fees.
 
#5
We are a EU startup and were able to make all the necessary documentation in about 7to8 months. Getting distributed by is way easier on a regulatory level off course, but a bad idea on a strategic level. When distributing under your own name, the original manufacturer still appears on your label.... For example if you find a good supplier with good quality, you are basically disclosing it to everyone.
 

nozzle

Starting to get Involved
#6
Agreed. Different businesses will approach this in different ways. The big problem for the smaller establishments is the auditing of the technical files. At one seminar I attended a speaker said his company had 50 technical files and the audit time could vary from 2 days to 2 weeks. On one product they ended up with a £15k audit bill for a product they sell £18k worth of.
We've moved to distributed by on some products while remaining VM on others.
 
#7
Strategically the business needs to decide how it wants to navigate the regulatory waters, neither distributed or VM is wrong, but the business needs to decide its approach. Fully distributed is the cheapest and easiest, while VM gives the business kudos and benefits that are harder to quantify while coming at an obvious expense. A mix of routes is also feasible and commonly employed

I do not believe that smaller companies will be able to justify or support the VM route from a resource perspective.
 

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