The Medical Device File can be easily accomplished by creating an MDF index. The index can simply list all the documents listed above or list what documents are needed to locate them.
Specification
For example, each label should have a specification.
Simply having a labeling section of the MDF index can list all the label specifications and their titles (do not include the version number).
The intended use is likely stated in the IFU, and if that is the case, under intended use, state, “see IFU, section X” (Section X being where the IFU is located and is likely in the labeling section).
Compilation of Documents
It should be noted the MDF is actually the compilation of all the documents listed but printing them out and keeping them current is a lot of work that is not worth doing.
It’s far easier to simply create an index and then provide whichever documents are desired.
The MDF is particularly useful if the organization decides to outsource the product, or sell the product to another organization.
The MDF provides the road map needed to make the product.