We have begun learning about the Design History File (DHF) this module. We are more than halfway through the course, so congrats for making it this far!

This module deals with the DHF contents and how to make one.

There is also something called a Device Master Record (DMR), which we do not go over much in this course, formally, but you will learn a lot about it if you take Advanced Medical Device Development, which I encourage you all to do next. I want to take some time to write about that and answer your questions here.

A DHF logs the design process. Simple. Once the product is created and Design Transfer is done, the DHF is closed, frozen. (There is another school of thought on this that I will get back to later.)

Once Production has the product, it needs a place to keep all of its information, such as the drawings, SOP’s, and other kinds of output created during the project. The place where this is kept is the DMR.

The DMR is a giant folder or index of practical things. By “practical”, I mean that the DMR should tell you everything you need to know to make the product from scratch. It will list every vendor, every raw material specification, every drawing, every SOP…. you get the idea.

If I drop a DMR and everything it references at your doorstep, and you have a multi-million dollar manufacturing facility in your back pocket, you should be able to make the product with no other information needed.

Sometimes, during a product’s life, it gets modified. Maybe instead of buying Raw Material A from Sears, you want to buy it from Target. That’s a vendor change. This change will be recorded in the DMR, not the DHF.

Maybe eventually you realize that an SOP is not clear. So you go through the change control process and change the SOP. You then put a copy of this new SOP in the DMR, not the DHF. Remember, the DHF is frozen. The DMR is active.

Any change to the product or the products paperwork goes in the DMR.

The DMR is largely used for US products. It is required by the FDA. The equivalent to the DMR for European products is called the Technical File (for European class I, IIa, and IIb devices) or the Design Dossier (for European class III devices). Like the DMR, these are live documents that are continually updated.

There is no DHF in European regulatory. They do not require you to log the development process. You only have to summarize it briefly in the Tech File or the Design Dossier. That’s a big difference in philosophy between the US and EU.

Now, there are some schools of thought that say the DHF is not static, and that it gets updated along with the DMR. So be it. You might see that sometimes, but it’s a pain to do that. As a device goes through its lifecycle, you will always be updating the DMR and the Tech File/Design Dossier. There’s no way around that unless you want to get severely crunched in an audit.

So here’s a question to make sure you are paying attention: Do you have to do Design Controls when making a medical device in EU? Why or why not?