Discussion on OBL and OEM test data for submission as per new EUMDR

shivani

Registered
Hello everyone,

Need clarification on following query,
As our client is under Brand labelling agreement being OBL and device is being manufacture an release by OEM under OBL brand name.

For obtaining CE certificate we understood that will need whole technical documentation as per new EUMDR, but this OEM and OBL have same devices in markets with their own labels and as they are equivalent to each other so is it possible to show all the test data performed on samples of OEM devices as they are equivalent device or we need test reports performed on only OBL device samples for submission to Notified body.

Thanks
 

Sharie Sanchez

Registered
Hello everyone,

Need clarification on following query,
As our client is under Brand labelling agreement being OBL and device is being manufacture an release by OEM under OBL brand name.

For obtaining CE certificate we understood that will need whole technical documentation as per new EUMDR, but this OEM and OBL have same devices in markets with their own labels and as they are equivalent to each other so is it possible to show all the test data performed on samples of OEM devices as they are equivalent device or we need test reports performed on only OBL device samples for submission to Notified body.

Thanks
Did you receive any respond?
 

EmiliaBedelia

Quite Involved in Discussions
If you have test data available on equivalent product, you can use that for your devices. You will need some kind of justification or explanation that the test report applies to a different SKU but I think you could easily write a memo that would cover all your test reports. If you have a BOM that clearly shows that the 2 devices use the same component and just have different branding applied, I think that would be an easy way to justify.
 

Vetty007

Involved In Discussions
As you have the OBL product included in your file and will very likely discuss the product with others in your documentation, you will already state that all data apply to a list of specified commercial products. Usually there is an overview of all trademarks and their specifications or any deviations and their UDIs, model nr. etc. and this will make it clear, what is covered by the data. In case of the reports you should however take care, that not only a product name is given, but rather also a product specification, that is as precise as possible, so that a direct reference can be made easily.
 

DrFergal

Starting to get Involved
I am unable to answer your question but we do similar to you and are the legal manufacturer using an OEM factory to produce our products. For one of the products, the OEM had an almost identical product fully tested however we chose to do our own testing with an independent lab to meet specific EN ISO standards.

The reason we did this was because a lot of our customers request copies of our test reports and it looks more professional (and less confusing for them) to have our company details and specific product names and MPCs on the report. In addition when tendering, most government organisations refuse to accept test reports that don't have a clear link to the product you have submitted (ie same manufacturer name, MPC and product name).

So it is worth considering if your client wants to do this for commercial reasons as well as just the regulatory requirements.
 
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