Design Responsibilities for Mature Acquired Product Lines

#1
If a company acquires manufacturing rights to a mature product line, what is their responsibility as regards documentation of the design files under ISO 13485 and 21CFR820?
 
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William55401

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#2
Hello Bruce. Welcome to the Cove! Clarifying questions. Who is the legal manufacturer? (In Europe, who is placing the product on the market?). In the USA, who is the manufacturer? My questions get down to who owns the regulatory approval pathway for the product. Is your org a contract manufacturer? Please share more detail. I am not sure what you mean by "acquires mfg rights...." comment. If your firm is responsible for putting the products on the market as the manufacturer, your firm also owns the current state of the Design History File, Technical Files, and Risk Management Files. If these assets are in great shape, no problem. If these assets are in need of remediation, your firm is on the hook to fix these to support current and future marketing of the mature product line.

Hope this helps.
 
#3
William, (actually, I am an old member. Just haven't been active for a while...) Here is the scenario. The company for which I now work obtained the rights to manufacture and service a line of medical devices (non0invasive laser treatment devices) which had been in the market for a decade. The previous company who manufactured the device is still around, but no longer manufacture these devices. I inherited the task of getting the new company through ISO 13485 compliance and EU MDR certification. Unfortunately, the books and records of the previous company are in a state of chaos. I need to reconstruct as much as possible. However, the people who designed the pproduct, over a decade ago, are not with the new company. I have no original documents with their signatures on any of the design documents I have located. I am not sure how to move forward.
 

William55401

Quite Involved in Discussions
#4
To keep it simple, you will need your leadership's support to be successful. Your organization, I suspect, did not complete a robust pre-acquisition due diligence process to understand current state of the technical documentation mentioned above. To get it right, it will take design, risk, and likely RA talent. (Read this as it will take investment from your org to remedy the distressed DMR, DHF, RMF, submissions, etc into a defendable state of control to support marketing in today's more rigorous environment).

Enjoy the ride!
 
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