Labels, Instructions for Use, drawings, Certificates of Conformity, and other documents might form part of a DMR.
The following contents are listed in the relevant chapter of the CFR[1] as part of the Device Master Record: (a) Device specifications including appropriate drawings, composition, formulation, component specifications, and software specifications; (b) Production process specifications including the appropriate equipment specifications, production methods, production procedures, and production environment specifications; (c) Quality assurance procedures and specifications including acceptance criteria and the quality assurance equipment to be used; (d) Packaging and labeling specifications, including methods and processes used; and (e) Installation, maintenance, and servicing procedures and methods.
Once everything is ready for switching to making the new design, the device master record is updated.
The DMR will specify exactly what plastic moulds to use, what software builds to install etc.
If an error is found in a product, the manufacturer may identify this problem to specific versions of the DMR, possibly using a CAPA, and may then choose to issue notices to customers for products, that have been built according to these versions of the DMR, or make a product recall.