Medical Device Master File - We are a contract manufacturer

#1
We are a contract manufacture, do we need a MDMF here or is that the responsibility of the customers. For example for one customer we manufacture bone screws in close to 30 different products. Would I need a MDMF for each one?

Thanks!
 
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Ronen E

Problem Solver
Staff member
Moderator
#2
Are you pursuing ISO 13485 certification?
Also, what are the target markets for these devices? Do you package and distribute direct (on customers' behalf), or do you ship "unfinished product" to your customers?
 
#3
We are 13485 certified. We ship product to customer who then distributes product to the field. I would consider it unfinished since we don't perform any sterilization or final clean.
 

Ronen E

Problem Solver
Staff member
Moderator
#4
We are 13485 certified. We ship product to customer who then distributes product to the field. I would consider it unfinished since we don't perform any sterilization or final clean.
I am confused.
If you are already certified (assuming the 2016 version), how could you pass s. 4.2.3 without having such a file?
 

yodon

Staff member
Super Moderator
#5
This and similar questions come up a lot here. Contract manufacturers aren't the legal manufacturer so they can't hold the complete medical device file. They likely don't care about the general description of the device, intended purpose, procedures for servicing, etc. They certainly need to contribute to the overall file; e.g., at a minimum, the specifications or procedures for manufacturing and the procedures for measuring and monitoring (during manufacturing). They may also be involved in the other aspects of 4.2.3(c).

I wonder if it's just how their QMS is framed. Does the QMS say "we do all of 4.2.3" or "here are the applicable portions that we do..."?

Regarding the question of one for each, the standard allows for a medical device file for a medical device family. I would think bone screws differing in just size would typically be included in a 'family.'
 

QE1993

Involved In Discussions
#6
We are a contract manufacturer. We state our Methods, which includes or references how to manufacture the product, drawings, specs, etc, is our medical device file. In my quality manual, I state that we do not legally know the intended use of the device, nor do we have requirements for labeling or final packaging.

We had an auditor tell us that it should be stated in our quality agreement with our customer if they are responsible for the device master record (or the medical file, per ISO). Not sure about this - anyone have any insight?
 

yodon

Staff member
Super Moderator
#7
I don't know if there's any statutory or standards basis for it but I (personally) think it's a good idea. (Although I've only seen the Quality Agreement coming from who would be your customer, not the CM - they're making the purchase.) It's what I do when compiling a Quality Agreement between one of my customers and their CM. Clearly delineate the lines of responsibility.
 

QM_123

Starting to get Involved
#8
We had an auditor tell us that it should be stated in our quality agreement with our customer if they are responsible for the device master record (or the medical file, per ISO). Not sure about this - anyone have any insight?
I prepare quality agreements for our subcontractor and I add a responsibility table which shows manufacturer and subcontractor are responsible for what. Enclosed you can see a basic example, subcontractor is you and manufacturer is your customer. The table is just an example I created it within 5 seconds and does not include all details, I just want to give inspiration. I hope this will help you to create something.
 

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