Contents of DMR (Device Master Record) when manufacturing is by 3rd party

We are a medical device company in the US and I have been given the job of updating our Device Master Records.

We are the specification holder, but the devices in question are manufactured, packaged and sterilized by a third party vendor. The devices are received into our company, inspected, and released for sale as-is with no further processing.

Currently our DMR references the only documents we have control of - incoming inspection, release, and the product specifications. Is this sufficient?

The FDA's Device guidance indicates that manufacturing procedures should be included in the DMR. However, since those procedures are written and controlled by the vendor, is it necessary to include them? We provide the vendor with the product specifications but not, for example, instructions on how to operate their molding machine.

Also, should the DMR include a narrative summary of the manufacturing and sterilization processes that occur by the vendor? What about a narrative summary of the processes we do perform (i.e. inspection, release)? Or is just a reference to our SOPs sufficient?

Any help would be appreciated.

If you are the device "owner", any third party processes (including the manufacturer in your case) has to be controlled under your quality system.

So the DMR would need to have all manufacturing processes, even if not performed directly by your company. And also of all the processes your company perform.

I agree with Marcelo. If you're the Manufacturer, you're responsible for the DMR. The CM is not. You may contract with them to do recordkeeping for you per Procedure X that you specify--just as you contract with them to do manufacturing operations for you, per multiple other Procedures and Specifications--but you are responsible for their performance of that DMR work on your behalf.

You must have procedures for the direct operations they perform for you, and for supplier qualification and supervision. You describe them as having a capable QMS, so you may want to work with them to adapt some of their procedures as yours, if they fit after such adaptation.