Question from my recent 3 hour webinar on the DHF ... EU MDR, and my response:

My question à Is a contract supplier who manufactures and ships a component that is used in a customer’s finished device required by FDA to have a component-level DMR?  Or is that more of a ‘if requested by the customer’ requirement?

Ans:  There's several ways to answer that.

The Specification Developer / Final Manufacturer (an FDA establishment classification) is the one who compiles the finished device documents, including the DMR (820.181 says the Manufacturer).  That is the Manufacturer who owns the device / 510(k). 

Contract manufacturers are manufacturing a device for the device "owner", so are doing it under the "owner's" documentation, per PO, and/or Contract. and/or Quality Agreement.  The same principle applies when a contract manufacturer manufacturers a device's component  or part - such manufacture is done per drawings, specs, PO, et al. developed by the top-tier manufacturer / device "owner" (usually the name on the device label)  .

In all cases, there has to be at least one DMR, the FDA CGMP requirement in 820.181, with the responsibility for compilation falling on the owner of the device, not a contractor.   

So if the customer wants a "component level DMR" that would be per a written agreement / spec / PO, et a,l between the two parties, but is not a CGMP requirement, per se. 

However, to perform the contact manufacturing of the component, the contractor would need some of their own unique documents / a partial CGMP-compliant system, mandating their own documents, such as possibly specs (could use the "owners"), drawings (could use the "owners), and  their own QC /manufacturing SOPs / WIs, equipment / operating parameters, validated, and the document that lists all those documents required for them to manufacture that part to the client's requirements. The contract manufacturer's SOPs would address what those documents and the document tying them altogether would be called (DMR / recipe / setup card ...) and how it all would be structured. 

-- jel@jelincoln.com