Hello Anon,
Generally, whichever company's name is listed on the label of the finished device would be considered the (legal) Manufacturer, though as said this can differ by region and what is stated on the label. As an example, in the United States the product labelling could say "Manufactured for Company A" so Company A is completely responsible for a quality and regulatory aspects, Company B would be the one actually making the device. Though I would say whosever name is listed on the device label in most jurisdictions would be considered the legal manufacturer taking on all responsibilities of quality and regulatory requirements.
This means the name listed on the device label can not say, "Oh, well we do not really make the device, so it is not our problem," which is a big misconception in the industry. The (legal) Manufacturer does have the responsibility so a producer or company making the device would be considered a supplier - even a Contract Manufacturer - still a supplier. So in your scenario, there will probably need to be multiple agreements generated or even some three-way agreements while the transition activities occur.
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Richard Vincins ASQ-CQA, MTOPRA, RAC
Principal Strategy Consultant
NAMSA
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Original Message:
Sent: 29-Mar-2024 14:50
From: Anonymous Member
Subject: Legal manufacturer applicability
This message was posted by a user wishing to remain anonymous
Hello Anon
It depends on how the two companies write the agreement.
One common arrangement is where the new owner receives whatever exists in the way of design history files, technical documentation files, 510(k)'s, etc., and becomes responsible for registration, CE-marking, and so on, while the original company takes the role of contract manufacturer / actual manufacturer. The new responsible manufacturer may have the ability to make design changes as needed, and transfer those changes to the contract manufacturer. Or the original company may be engaged as a contract designer to make design changes, assuming they still have those skills and haven't stripped down to only manufacturing.
Original Message:
Sent: 28-Mar-2024 16:39
From: Anonymous Member
Subject: Legal manufacturer applicability
This message was posted by a user wishing to remain anonymous
A manufacturer of medical devices is contemplating to sell the intellectual property and commercialization rights of a medical device to another company. However, the original developer will continue manufacturing the device for the new owners.
Who is the Legal manufacturer? Is it the original developer that will continue manufacturing the device, or the new company as the device owners?
What determines the legal manufacturer role and is that a constant in all territories or is it different in the USA vs EU vs APAC?
Thank you all in advance!