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

  • Thread starter NicoleinFlorida
  • Start date
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NicoleinFlorida

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.
 

pkost

Trusted Information Resource
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
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

Involved In Discussions
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.
 
G

Gregski

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

Involved In Discussions
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.
 

pkost

Trusted Information Resource
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.
 
M

mdalkhen

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.

Dear Nicolein,

can you give me your contact details, I am also in the same process of starting an OBL and I would like to talk to you about a couple of things if you do not mind.

Regards.
 
M

mdalkhen

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.

Hi Gregski,

may i know your company details to be able to contact with you?

Regards.
 

RobertvanBoxtel

Involved In Discussions
Dear All,

As identified above, NB's are already not accepting anymore the previously "acceptable" OBL constructions. In the EU MDR (and IVDR), you can find in article 10 the requirements that a manufacturer needs to fulfill. The manufacturer as defined in the definition section.
Hence, you can only place products in the EU market if you can demonstrate meeting these requirements, and, amongst others, have followed the applicable conformity assessment route as identified in article 52.

In practice: all manufacturers will need to be able to demonstrate all technical documentation and have the relevant QMS to maintain the technical documentation over the life cycle of the product.
 
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