Under the MDR the manufacturer has all normal responsiblities, also when white labeling (see article 10 (8) 2nd para: you must have full technical documentation). For MDR purposes the REAL manufacturer is not the company producing the device but the company that places it on the market under its own (trade)name or trademark, see the definition of maufacturer in article 2 MDR. Depending on what you mean by generic it is possible that the OEM licenses out a number of identical sets of full technical documentation plus provides RA assistance to the various private labelers in the market. So how you do this is by setting up a good agreement that allows the private labeler to be the real manufacturer but obliges the OEM to facilitate that as much as possible. This is called a virtual manufacturing agreement and the MHRA has issued guidance at some point xon what should be in that when the UK was still in the EU. Some notified bodies also have checklists for this type of agreement.
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Erik Vollebregt
Partner
Amsterdam
Netherlands
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Original Message:
Sent: 18-Jul-2022 10:04
From: D Michelle Williams
Subject: White Labeling
Good Day everyone....
I'm curious to know what experience is out there with this. How does a company who is white labeling create a technical file that requires manufacturing process and materials used to make the product if they are not the REAL manufacturer of the product? Do countries accept an a generic process and a generic list of materials?
Thanks,
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D Michelle Williams
VP - Operations
United States
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