Own Brand Labellers Manufacturer's Products (Class I and IIa) and Risk Assessments

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claireyvb

Hi Covers,

What are people's takes on the conduct of risk assessments for own brand labeller manufacturer's products (Class I and IIa)?

To expand: We are an OBL in UK who buy Generic Medical Devices that are already CE Marked and available on the market and literally have the product put into our Product livery by the OEM. We then register it with ourselves being the legal manufacturer with an NB/MHRA as applicable.

We receive the OEM's risk assessment as part of the Technical File and we have outgoing and incoming QC inspections on each lot shipped to/received by us. Neither the product's function nor its internal design are amended in any way. Should we, as unskilled individuals, be conducting a secondary risk assessment on the products?

Thanks for your input in advance.

Claire
 

rob73

looking for answers
Re: Own Brand Labellers Manufacturer's Products (Class I and IIa) and Risk Assessment

Claire
I think it would be appropriate for to do a risk assessment/analysis based on your own activities,this would be to ensure that you are not generating additional risks not identified by the OEM.
Rob
 

jkuil

Quite Involved in Discussions
Re: Own Brand Labellers Manufacturer's Products (Class I and IIa) and Risk Assessment

In your technical file you should also record that you have evaluated the OEMs risk assessment and have accepted the residual risks identified in the risk management report. As you are the legal manufacturer you must ensure yourselfe that you do not put any device on the market that has an identified or unidentified unacceptable risk associated to it. If you have any concerns with the risk assessment provided by the OEM you can put that into an amendment or note to file. By this means you provide evidence that you, as the legal manufacturer, have assessed and evaluated all risks
 
C

claireyvb

Re: Own Brand Labellers Manufacturer's Products (Class I and IIa) and Risk Assessment

Rob/Jan,

Thanks for your replies. These are really helpful!

Claire
 
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