Ownership of Design History File

JoCam

Trusted Information Resource
Hi All,

When you use a sub-contractor to assist with the design of your product and to manufacture it for commercial release who should hold the Design History File?

Thank you in advance,

Jo
 

somashekar

Leader
Admin
Primarily the product owner, but if you have set an agreement that the sub-contractor of design to maintain the DHF, and be available to you at short notice, it should still work.....
 

JoCam

Trusted Information Resource
Thank you Somashekar,

Should the owner review and approve the documents in the DHF, or can the responsibility for this also be passed to the sub-contractor via technical agreement, or something similar?

Jo
 

rob73

looking for answers
If you are placing the product on the market under your own name i think it would be prudent to review the file as if you where doing a CB audit. At the end of the day it is your responsibility for the devices safety and performance, no matter who manufactures it.
Further to Somashekar's comments, attached is a "contract" for own brand labeling that could be adapted to suit sub-contract manufacture.
 

Attachments

  • OBL Agreement typical.doc
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RCW

Quite Involved in Discussions
Hi All,

When you use a sub-contractor to assist with the design of your product and to manufacture it for commercial release who should hold the Design History File?

Jo

Jo,

You stated "manufacture" in your question above. That would involve the Device History Record (DHR) which is yet another item.

My company does both contract design and contract manufacturing of medical devices. We require our customer to sign-off on the design records as they technically own the design. They have copies of the DHF at their facility but they also have my company maintain the original / master at our facility.

When it comes to the DHR, again, the master is maintained at our facility with our customer asking to provide them copies of it upon request. A few customers have set up web-based portals for us to upload the DHR to upon completion of the device.
 

JoCam

Trusted Information Resource
Thank you RCW,

Your company operates as I believe it should, and in previous employment this is exactly how I ensured the DHF's and DHR's were controlled. However, at my present place of employment on requesting a DHF from a sub-contractor I was pretty much told that I don't need it, and that a list of the documents it contains should suffice, which apparently is sufficient for their other clients, including pharmaceutical ones. I need to check where I stand on this before I start pushing the matter.

I know that the DHF should be held by the product owner where the FDA is concerned, even if statements to the contrary exist in signed technical agreements, but can the same be said for Europe? Is a list of the documents a DHF contains adequate for this territory?

Jo
 

RCW

Quite Involved in Discussions
However, at my present place of employment on requesting a DHF from a sub-contractor I was pretty much told that I don't need it, and that a list of the documents it contains should suffice, which apparently is sufficient for their other clients, including pharmaceutical ones.

YIKES!! :mg:
This is your sub-contractor telling you this?
If so check what agreements you have in place with them. Watch them closely and consider looking for another sub-contractor.

As a sub-contractor, I will support my customer as much as I can but as previously stated here, ultimately your company is responsible in the eyes of the regulators.

Good luck with this!
 
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