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?
Spiral Medical Development
www.spiralmeddev.com
Yes, Design Controls would be needed for a medical device in the EU. While there would be no DHF needed in the EU, most of the parts of design controls would still be needed, such as the: PDF, DDP, DID, etc. So almost all sections of the design controls are needed in the EU, but the full Design History File would not be compiled.
http://www.mastercontrol.com/newsletter/medical_device/medical-device-design-history-file-0710.html
-Andrew Nashed
Yes, while a DHF is not needed for an EU release product, design controls are still an integral part of the process and are still integral. While that may be the case, I believe any company looking to expand its platform to an international level, can always beneifit from "over documentation" and having a DHF on hand and constantly updated. This may make things easier when marketing the product to the US.
-Tarek
So while the document is not nessarly exactly like a DHF, a document similar to it is needed. Since the an origin of this document is the Formal Design Control and Design History File (DHF) requirements which are parts of GMPs that were instituted and set by the FDA in 1996-1997. Similar design controls are required in europe. Europe does require a documented design history incduing aspects of the the DHF in the US.
Hi,
I agree with the above discussion . Design control is required for the EU release product .Actually DHF is used only before product release .Once the product is commercially released ,all changes are under production control and all changes must be documents in the DMR/technical file.
As per 21 CFR Part 820 DHF means compilation of the records which describe the design history of the finished device. But when compared to the ISO there is no specific requirements for Design history file, but how ever to market the product in US , manufacturer must comply with the FDA quality system regulations , which require DHF.
Both the FDA Design control and ISO design and development expect you to keep documentation and record throughout the product development process.
“The DHF is mandated by the U.S. FDA, and describes a product through its development cycle, under Design Control, with its output being the DMR (Device Master Record) which defines the product as currently marketed. However, the EU (European Union) under the Medical Device Directive (MDD; EU Council Directive 93/42/EEC) and for CE-Marking, requires a file describing the product at a point in time, i.e., as currently marketed in EU / Common Market countries, similar to the DMR, with elements of the DHF, such as risk management documents, and clinical data. “
This file is either the Technical file or Design Dossier. The article I found about this lists the general make up and requirements in design controls, as well as the requirements for these documents. Generally, the Technical file or Design Dossier (depending on device class) will include:
• General Information / Product Description / EC Authorized Representative
• Classification Determination (Annex IX, Rule [select applicable rule])
• Essential Requirements (Annex I)
• Risk Analysis
• Labeling
• Product Specifications
• Design Control
• Clinical Evaluation (Annex X; literature review, et al.)
• System Test Reports
• Functional Bench Testing
• Lab Testing (cytotox, hemolysis, sensitization, carcinogenicity, other biocompatibility testing)
• Sterilization validation (or AAMI TIR 28 Analysis)
• Packaging Qualifications
• Manufacturing
• Sterilization
• Conclusion
• Declaration of Conformity (Annex II, V, VII)
• Appendix (further supporting information / details on the above).
Source: http://www.mastercontrol.com/newsletter/medical_device/medical-device-design-history-file-0710.html
The last post here is the most accurate. Design Controls are not "needed" in the EU in the sense that they are not mandated by a regulatory body like they are in the US. Granted, it is still a good idea to use something like Design Controls as a coherent design process to catch errors before the product is launched, but it is not mandated.
Like the post above suggests, EU regulatory looks a device development as a snapshot in time in the Design Dossier or Tech File (depending on device class). A DHF looks at the whole complete design process from beginning to end and tracks the rationale at each step.
How would you compare these two philosophies? What are their pros and cons?
Spiral Medical Development
www.spiralmeddev.com
Coming from the "Continuous Improvement" mindset, I would think that the "snapshot" that EU regulatory bodies focus on is really only from a practicality standpoint. Each time the EU regulatory bodies perform an audit, they are looking for issues at that time, not necessarily from 10 years prior- though that’s not to say those documents are off limits.
As far as the philosophies go, I think that having the entire process documented with rationale is extremely important. I’m currently struggling to understand decisions that were made years ago to the process that are causing difficulties now and trying to figure out how my changes will affect those decisions and vice versa. The documentation aspect is required, but also vital to the improvement of your device. Similar to the saying that history is doomed to repeat itself, there is nothing worse than performing a ton of work only to later realize it was done before and had the same result, or even to undo work only to find the same problems.
The information cannot live in the minds of the creators of the device, it has to be written so that it can be used to improve. I think the requirement for the DHF is the better way to go to make sure companies are not hurting themselves later.
I agree that there exists an advantage to have the entire design process documented in a DHF versus a snapshot of the design process with the Design Dossier or Tech File. For one thing, we are able to see every aspect of the product from start to finish. It is the proof that the product was designed to be safe, meets user needs and requirements, and is of upmost quality. The fact that EU regulatory does not require the DHF shows that US FDA controls are much tighter and stricter. This can be a disadvantage for US products that want to be out in the market, but are delayed due to strict FDA regulation. However, if it means producing a high quality product, these controls are needed.
It seems that the DHF is superior to the Design Dossier or Tech File in it's thoroughness and documentation and that is why there seems to be a move in the EU toward the use of a DHF instead.
From the same link that pt58 posted: "Newer EU regulatory guidance documents are moving the TF/DD more in the direction of the DHF. However, a review of both descriptions above shows much commonality already, allowing the development of both files (DHF and TF/DD) almost concurrently, while supplementing the DHF with the DMR for a current TF/DD."
AS sdl3 said, the Design Dossier or Tech File can be beneficial for audits as they only have to look back at the material that was updated since the last audit because of the new 'snapshots'. I think this method can also be helpful if a product starts to fail after a change in design. One can easily compare the different snapshots and see where the design failed. I believe the DHF is better in certain apects. It contains everything from start to finish and is continuously updated leaving nothing out. Essentially the DHF would contain everything a Design Dossier or Tech File would but with more information and in more detail. This could help the company if they want to change the product in anyway, cut down on costs, change supplier, etc.
At first before reading the other comments I thought that design control was needed in the EU, but I saw that it is not mandated unlike the US. The pros in a DHF are that allows you to see the growth and changes within the design process each step meaning the changes that may occur for at any instant; for example what if the raw material may need to change, because they found it a better option. Unlike EU you wouldn’t pay it any mind that the raw material changed, because you are only focused overall development, not the small details. Which are the most important in my opinion they can make or break a product?
I think the DHF mindset of continuously documenting the "whole story" is more beneficial than the EU approach, where the design is evaluated at a single point in time. I think that documenting the entire development process and rationale for key decisions (which is done in the DHF) is advantageous when issues arise in the manufacturing of the device, for example. Its easier to identify the solution to a problem when you know the entire design history and limitations of the product. Its useful to know what controls are in place to manufacture a quality product and what happens when each individual control is not in place (e.g. if a raw material specification is slightly off, how does this affect the quality of the device?).
That is interesting, before I red Dr. Simons comment I also thought it was needed as a lot of the things in the deism control seem to be standard steps in device development. In terms of which one is better I also think that the continuity of a DHF makes more sense instead of the snapshot. Snapshots do not tell the whole story and can be misleading. Having information on the device throughout its life cycle helps to tell a story and this is handy when troubleshooting or years later if you need to find some type of documentation
Design controls may not be required for Europe, however they can come in very handy with the Design Dossier or Technical File. Logging the development process is good practice and should be done regardless if it is required. If the company is US based and starting up an office or sub-company in Europe, it would be wise to adapt to the European Dossier and Technical file while incorporating practices of the DHF and DMR.
