DMR - Device Master Records - What is the best way to structure the DMR

[Al Rosen]

hello everybody,
I work in a large company that manufactures parts for many different industries. Recently, I've been appointed to follow one of our plants which provides finished goods to the medical market. My role, and I know many of you do not like it, is STA (SQA, SQE, SDE, or whatever you call it). My background is automotive, and I am learning right now what the medical world is all about.

The point is:
Are supplier supposed to have a DMR (I think yes, to a reasonable extent we have to agree)?
shall I require suppliers to send us their DMR?
How similar the DMR is to an automotive PPAP file?

Thanks in advance

DMR is not a PPAP and suppliers who do not place the device on the market are not required to have a Device Master Record as such, although you may have some of the documents identified in the DMR.

 

[RCW]

DMR is not a PPAP and suppliers who do not place the device on the market are not required to have a Device Master Record as such, although you may have some of the documents identified in the DMR.

A couple of different angles here:

1) Implied from above, if I am a contract manufacturer of medical devices, I don't need to generate my own DMR. It is the responsibility of the company that owns the design and markets the medical device. (TRUE?)

2) If I am a contract engineering service for medical devices BUT I don't own the final design, I don't need to generate a DMR (unless it is a contract requirement with the customer). (TRUE or FALSE?)


So if the above 2 items are true, it would be safe to say the company that has registered the device is responsible for the DMR.

(Sorry for sounding so redundant but I have some "higer ups" on my back and I want to get this resolved properly.)

 

[Al Rosen]

A couple of different angles here:

1) Implied from above, if I am a contract manufacturer of medical devices, I don't need to generate my own DMR. It is the responsibility of the company that owns the design and markets the medical device. (TRUE?)

You still need all the documentation required to manufacture the device, but you may not have the labeling. So, it depends.

2) If I am a contract engineering service for medical devices BUT I don't own the final design, I don't need to generate a DMR (unless it is a contract requirement with the customer). (TRUE or FALSE?) [/quote]True, if you are not manufacturing the device. The DMR addresses manufacturing.

So if the above 2 items are true, it would be safe to say the company that has registered the device is responsible for the DMR.

(Sorry for sounding so redundant but I have some "higer ups" on my back and I want to get this resolved properly.)

It depends on your involvement. If the company that places the product on the market does not manufacture it, they will flow down the requirements, but maintain responsibility. Bottom line is that you need documentation to manufacture.

 

[Watchwait]

Old thread - probably even older questions...but here goes anyway:

From the FDA QSR perspective :

Does the Device Master Record Index (a list of all the documents comprising a device) itself need to be under change control? (yes or no; black or white question).

Is it permissible to leave the revision levels off the documents comprising the Device Master Record Index? (instead, a document would be listed as 12345-xxx where "xxx" is the latest and only active version of the document available.) Again, Yes/No (no: "it depends..." allowed.

 

[mickb]

My interpretation of 820:40:

(a) Document approval and distribution. Each manufacturer shall designate an individual(s) to review foradequacy and approve prior to issuance all documents established to meet the requirements of this part. The approval, including the date and signature of the individual(s) approving the document, shall be documented.

So yes, this is a document

Going a bit further on 820:40

Each manufacturer shall establish and maintain procedures to control all documents that are required by this part.

We have a procedure for maintenance of the DMR and in it there is definition of the details we record. The FDA were happy with this approach, we do not maintain the DMR to show latest revision levels of documents, however if a document is made obsolete or name changed then the DMR is amended.

Our procedure permits rolling amendement of the DMR through redlined, handwritten changes (by approved persons) and Quarterly Approval by Management. Again FDA were happy with this.

 

[Watchwait]

Very similar to the approach we are proposing.

Hope we get input/feedback from others on this...

 

[ken11356]

Re: DMR is a document

if you have a template for DMR that i could incorporate into my tech files to make 1 book, i would really appreciate it.

thanks

ken

 

[GStough]

Re: DMR is a document

if you have a template for DMR that i could incorporate into my tech files to make 1 book, i would really appreciate it.

thanks

ken

Hi Ken,

Welcome to the Cove!

Did you see the attachment posted by pbojsen on the 1st page of this thread? There are probably others posted in the Post Attachments List (see the thin green bar in the upper left corner of this screen), when you have time to browse...

Hope this helps...

 

[The Capt - 2011]

Hello, new guy here and I just came into medical field.......from automotive and a few other fields.

Reading the posts about the DMR, and seeing that it is quoted not to be like a PPAP.

Can I assume that because we do not own the design of the product that we are only required to have documents in our DMR that maps our process to produce the parts?

 

[MIREGMGR]

Can I assume that because we do not own the design of the product that we are only required to have documents in our DMR that maps our process to produce the parts?

I assume you're telling us that you are a Contract Manufacturer, per the FDA's definition. Presumably you're aware that your customer has to fit the FDA's definition as well, i.e. in addition to owning the design of the product, they have to be its marketer, or be regulatorily responsible for that marketing.

If you are an FDA Contract Manufacturer, your regulatory responsibility is only for those processes you perform for which the FDA has a general requirement for process validation, and for regulatory registration if the processes you perform include or substantially affect sterilization. Your customer will have full regulatory responsibility for all of your actions; your narrow responsibilities as defined will be in parallel with some of the customer's broad responsibilities.

As a Contract Manufacturer, you are subject to for-cause inspection if an FDA inspection of your customer, a review of one of their regulatory filings or an adverse event involving one of their products causes the FDA to believe that actions taken by you may be a contributing factor to a problem involving safety or effectiveness. Determination of who is responsible for whatever is found during such an inspection generally is after-the-fact.

If you are registered with the FDA as a Medical Device Establishment because you separately have activities for which you are a Manufacturer (as opposed to a Contract Manufacturer, per FDA definitions), it's possible that your Contract Manufacturing activities might be held to a higher expectation-standard during an inspection because the FDA would assume you should "know better".