Device Master Records for a Contract Manufacturer

SGquality

Quite Involved in Discussions
In reading the DMR requirements, it is definitely the customer responsibility to prepare and maintain a DMR.

But is a Contract Manufacturer required to prepare a DMR based on the manufacturing process and including all information relating to Customer Drawings, Specifications, List of SOPs and so on ?
 
V

Vthouta

We are a contract manufacturing company building electronic pcb's for our medical customers. We have not been told by any of our multinational top tier medical OEM's to maintain DMR, but we have to retain the files as per the ISO 13485 for example job routers and if an existing assembly or product is called off by the medical OEM, we archive all the files i.e. specifications, drawings and work instructions as per the clause 13845.

Vik
 

Ronen E

Problem Solver
Moderator
In reading the DMR requirements, it is definitely the customer responsibility to prepare and maintain a DMR.

But is a Contract Manufacturer required to prepare a DMR based on the manufacturing process and including all information relating to Customer Drawings, Specifications, List of SOPs and so on ?

Hi,

1. Please note that (based on precedents) FDA might hold the Contract Manufacturer as the primary regulatory-wise responsible party, and thus part 820 would apply in full.

2. Even if not mandated by the regulation directly, the requirement for a DMR (or the equivalent) might be transferred to the CM from the Spec Developer (the client) through contract. Often, the client would not have the ability to devise and maintain a full DMR, and the CM would not be interested in sharing all the device specs / manufacturing specs that the client would need for a compliant DMR.

3. It's most likely, if a CM serves the medical devices industry, that they already have all the records (and supporting procedures) that would make up a compliant DMR, whether they call it that or not. True, if no initiative is taken in that direction it might be cumbersome to immediately present or collect 100% of those records at any given moment, but probably not impossible if given a bit of time and attention. That (already existing) collection might be considered "the DMR" (albeit a deficient one) if no other arrangement is intentionally made.

Cheers,
Ronen.
 
P

PBuckley

Hi,

1. Please note that (based on precedents) FDA might hold the Contract Manufacturer as the primary regulatory-wise responsible party, and thus part 820 would apply in full.

2. Even if not mandated by the regulation directly, the requirement for a DMR (or the equivalent) might be transferred to the CM from the Spec Developer (the client) through contract. Often, the client would not have the ability to devise and maintain a full DMR, and the CM would not be interested in sharing all the device specs / manufacturing specs that the client would need for a compliant DMR.


Cheers,
Ronen.

Heartily agree with Ronen on these points. As a specification developer who has contracted out manufacturing to a 3rd party, we rely on the third party to maintain DMR's using drawings, specifications, and procedures we supply to them, and DHF's showing manufacture and final release of finished product. They have agreed to provide this documentation to us upon request, (within a reasonable time frame of course). This is accomplished through contract, negotiated and agreed to by both parties. :agree:

Paul
 
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