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.