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?
Yes. it is important that you design and develop a medical device that is safe. FDA and EU and all other regulatory bodies throughout the world will want some assurances that your medical devices is safe before you bring the product to market.
Unlike in the US, design controls are not required in Europe to release a product. I personally prefer the American method of requiring a DHF and DMF, specifically when the DHF is treated as an unchanging document while the DMF is modifiable. Documentation is important, especially when you need to refer back to something done previously. By having two documents to refer to; one that is edited and one that remains the same, you can easily refer back to specific points without having to worry about being unable to access data that has been written over. By requiring this through law, the FDA has ensured that all steps of the design process are recorded and thus can easily be reviewed if an error arises. If you don't keep careful track of what has been done, it can often be near impossible to review all parts of a process when it potentially fails.
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.
While the regulations for medical device documentation between the US and EU vary, there are still some basic qualifications every company must submit in order to be complicit. In the US, it is a DHF and DMR which are required to show the extensiveness of documentation which as occurred and may be later useful should the FDA need to run an audit. The EU on the other hand, does not require the DHF, but does ask that the "Tech File or "Design Dossier" be submitted as a review of the documentation of design controls for the company. In such, yes, design controls are indeed a necessary element for a company to include in the medical device.
As a student, I recognize that when developing a medical device in the European Union (EU), the regulatory framework differs from that in the United States. In the EU, there's no specific obligation to maintain a Design History File (DHF) as is the case in the US. Instead, the focus lies on the Technical File or Design Dossier, which acts as a summary of the development process rather than a detailed, ongoing record similar to the DHF. This distinction arises from a difference in regulatory philosophy. EU regulations don't explicitly require the extensive documentation of the design process through Design Controls because they place greater emphasis on the final product's performance and safety. However, it's important to understand that while Design Controls may not be a strict regulatory mandate in the EU, they remain a valuable practice to ensure that medical devices meet the industry's expected quality and safety standards in both regions.
