Contract Manufacturer - Technical/Device Master File Responsibility

After following this site for a while I hope there is someone here that can answer my question. I hope I have explained it okay and that it is in the right section of the forum.
My company has a mature quality system in place (medical devices) and all the requirements that go along with it. Recently other companies have asked us to make devices (Class I/FDA or Class IIa for EU) for them. We in turn would purchase the devices from them for our customers. After reviewing the requirements for a Contract Manufacturer I cannot find out who is responsible to create and maintain the technical/device master file, us or them. We are not doing any labeling nor design. These products have been made before by other companies and are not new to the market. Neither of the "owners" do any manufacturing. If these were our products they would fall within the scope of products we already make and would not have a seperate technical or DMF of their own, just included in the file with the other products. One of them has mentioned being able to access the files if they need to which is not permitted under our QS.
I would like some further information before I discussing this topic with them. How do others handle the paperwork in this case?
I appreciate your help.

Medic61,

I’m a little confused by your post, but bear with me and hopefully we can work this out.

The entity placing the medical devices into commercial distribution within the EU is responsible for establishing and maintaining the Technical File. This being said, it is not uncommon in the case where a company Own Brands (private labels) a finished device from another manufacturer to piggyback on the manufacturers Technical File. Generally speaking the organization that is private labeling a device makes reference to the original equipment manufacturer in their Technical File. Depending on your registrar and their requirements for substantiating key responsibilities under varying scenarios (under which Annexes the QMS for the manufacturer of the finished device is registered along with the Annexes for product certification), the contents of the Technical File for the distributing party will vary.

Here are some tidbits to consider and might help to shape our conversation here.

· Medical Device Company A designs and markets a finished device in the EU. They are the legal manufacturer and must have a Technical File.

· Medical Device Company D Own Brands/Private Labels a finished device from Company A and markets the device in the EU. Company D is the legal manufacturer and must establish a Technical File in full or piggyback off of Company A’s Technical File.

At the end of your post, you mention that one of your customers’ hopes to have access to your technical documentation. This sounds to me as if they might be Company D and assume you to be Company A. If you confirm that you aren’t the legal manufacturer, then the company you are buying from is likely Company A (you’re just a middleman). I get the impression that you are just a middleman in that you claim not to have any design authority and because you are not performing any labeling operations. It sounds like you buy medical devices from Companies A, B and C, kit them in some fashion for Company D who in turn does the commercial distribution into the EU. Assuming Company D is using the products manufactured by Companies A, B, and C according to their labeling and intended uses, confirmed them for compatibility, and have not created a new medical device in the process, they would need a Technical File. This would either be in full or one that references the Technical Files of Companies A, B, and C for technical product documentation and your organization as the CM who kitted the product according to Company D’s specifications under your QMS registration.

As I said, I might be off the mark based on my interpretation of your post. Correct me where I am wrong and clarify based on my input here.

Regards,

Kevin

Whoever sells the product with their name on it automatically is ultimately responsible for regulatory compliance, regardless of how much or how little actual manufacturing they do. That includes maintaining relevant technical documentation to support the safety and effectiveness of the product.
Of course they can outsource some or all of the activities required.


In some private label situations the "real" manufacturer (aka OEM) doesn't want the "regulatory" manufacturer (aka PLM) to have access to technical data. That makes things complicated, but can be managed via agreement that the OEM will provide the technical documentation upon demand to regulatory bodies.

Thank you Kevin and Roland,
That is the way I feel, they are responsible for the technical documentation for the EU but what about the FDA device master file? Should I post another question in the FDA forum?

Well I lost the battle...it seems they do not do any design since they do not manufacture anything. All they do is labeling and depend on others to do the regulatory documentation, so more work for me.
Thanks to everyone who read and or answered the post.

medic61 said:

Well I lost the battle...it seems they do not do any design since they do not manufacture anything. All they do is labeling and depend on others to do the regulatory documentation, so more work for me.
Thanks to everyone who read and or answered the post.

Click to expand...

Doesn't making labels/labeling need Artwork or something. Could that not be considered Design? Just curious. I don't know much about Medical Devices.

medic61 said:

Well I lost the battle...it seems they do not do any design since they do not manufacture anything. All they do is labeling and depend on others to do the regulatory documentation, so more work for me.
Thanks to everyone who read and or answered the post.

Click to expand...

Just be a little careful here.

If "all they do" is determine what the clinical information on the labelling is to be, and they perform an overlabelling operation then they have involvement in both a design function and also in a manufacturing function.....

"

• How can it be avoided that supplier companies are audited several times in the contextof their purchasers' certification procedures?
• How can a manufacturer's full quality system be certified if the sales (and hence also parts of the post-market surveillance system) are organised via the specialist trade or parts of production and quality testing are subcontracted?
• Which conformity assessment procedures (annexes) can dealers or pure sales organisations apply?
• Which requirements are imposed on OEM devices and their manufacture?"

for answers Guidance Document attached...source: http://www.zlg.de

Medic61,

It appears that you have got the attention of some experienced personnel. I suggest that you pursue this a little further if you like.

Coury makes a good point. It has been my experience that certain organizations underestimate their involvement. When folks private label a finished device, they sometimes forget that despite not having design or manufacturing involvement, they are often times the legal manufacturer (owner). Curiously, the device looks and operates just like the OEM providers. Subtle configuration changes in labeling artwork might be all that separates product A from product B. As Roland says - be careful. Understand your organizations involvement/role and protect it. Read the attachment from jkonholm as it provides good detail. This stuff can be tricky and it is complicated by the flexibility provided by the directive. There is more than one way to skin the cat. I learn this well from my peers here at the Cove all the time.

Regards,

Kevin

medic61 said:

After following this site for a while I hope there is someone here that can answer my question. I hope I have explained it okay and that it is in the right section of the forum.
My company has a mature quality system in place (medical devices) and all the requirements that go along with it. Recently other companies have asked us to make devices (Class I/FDA or Class IIa for EU) for them. We in turn would purchase the devices from them for our customers. After reviewing the requirements for a Contract Manufacturer I cannot find out who is responsible to create and maintain the technical/device master file, us or them. We are not doing any labeling nor design. These products have been made before by other companies and are not new to the market. Neither of the "owners" do any manufacturing. If these were our products they would fall within the scope of products we already make and would not have a seperate technical or DMF of their own, just included in the file with the other products. One of them has mentioned being able to access the files if they need to which is not permitted under our QS.
I would like some further information before I discussing this topic with them. How do others handle the paperwork in this case?
I appreciate your help.

Click to expand...

What you detail is very common in the present complex global medical devices market. Perhaps the best way is by having clear quality management system agreements that describe the responsibility and authority of the various processes, which also mentions who the process owners are and what are the links between them. It is better such agreements are seperate from other agreements and are signed off by responsible quality heads and management. The ZLG document helps and is very informative. Also see through the MHRA site.
Good luck.
Somashekar, INDIA