Recent Webinar Q&A on the DMR:

QUES: About Device Master Records : Does a listing of documents which are registered on other files can respond to the DMR? For instance if we have the document that needs to be on the DMR on the technical file is it acceptable to not put it on the DMR ? Or do we need to have all the documents in the DMR? In case of subcontracting for the manufacturing of the device : some documents as for instance equipment tests are specific to CMO and we, as order giver don’t have these documents in our system. Is it also acceptable to only mentioned it on our DMR?

ANS:  The DMR is the device “recipe” for your company.  It could include a BOM, assembly SOPs, test SOP, a “Traveler”  having check offs for Line Clearance, Label Reconciliations, operating settings / ranges with operator and QC initials, specs, et al (see 21 CFR 820.181).  

The CMO should have their own DMR for the component(s) they are manufacturing for you, and you would show that completed component P/N that you receive from them on your DMR (that would translate through to your technical file). 

If you are the spec developer not just for the completed device, but also for the components built by the CMO, then you may have to include that P/N’s assembly in your DMR / Technical File.  That may be determined by how the part was developed, who developed it, the contractual arrangements with your CMO, any CMO Quality Agreements with your company, etc. 

When dealing with a CMO the final / parent company has to ensure that all regulatory requirements have been addressed totally, which by the CMO (verified by the company), and the remainder by the company.  The company is ultimately responsible for complete compliance.

I answered the above based on the US FDA / CGMPs; but similar points could be made for the EU MDR and ISO 13485.  

-- jel@jelincoln.com

Typo corrected 08/11/23 - JEL