I think the DHF is more useful than the tech file. With a complete DHF it shouldn't be difficult to get the actual design of the device as that is where the SOP is. The tech file is just a snapshot and not that detailed. My assumption is you would use a tech/file for a quick synopsis for a quick filing or something like that.

In my opinion, the tech file/dossier is more useful. The reason being is that it gives an overview to the entire product and design and is most useful to someone that was not heavily involved in the device’s development. This is most useful when device failures come to light for someone that was not directly involved in the project but is responsible for rectifying the issue. It can also be helpful for someone who worked on the product but cannot recall all of the details due to a passage of time. It also holds of the documents to meet essential requirements, which is most useful during an audit.
Once instance that I can think of that a DHF would be more useful is during the development stage of a similar product. For example, if a new syringe containing a hormone supplement, with a dose of 100-microliters, is being developed and previously, a similar product with a dose of 50-microliters was developed, a DHF of the 50-microliter dose would be most useful because things like packaging, labeling, storage, etc. can be used as a starting point for the new, 100-microliter product. If a similar approach is being used to develop the 100-microliter syringe, a team could avoid the failures and obstacles that were already previously explored while developing the 50-microliter syringe.
-Michelle F

I believe the DHF to be more valuable than the dossier. I base this off the fact that the DHF is fully auditable by the FDA. Everything from the customer need, risk analysis, design input and output, drawings and verification and validation. These are very valuable in terms of building a product from start to finish with all the associated files. In fact, a tech file may well be included in the DHF in terms of design input from the drawings provided.

Definitely great points made, but with the DHF even though it contains all revisions, changes, and mistakes from the devices inception it will also contain design input requirements and user requirement specifications. This essentially gives an overview of the device similar to the technical file. I believe though in the end the DHF would be more useful than the technical file because it contains all aspects from quality system regulations to verification/validations, which shows the planning and that proper documentation was kept throughout.

The DHF and Technical file are different documents that have the same content. The Technical File is a snapshot in time of the design without giving much consideration to the design history or the mistakes that were corrected along the way. In my opinion, the EU regulation was built in a way to guarantee that the design is safe and effective in its current form without much consideration to older versions. In their prospective, it is perfectly okay if after 10 design changes the design was modified to become in its original form again as long as the device in its current form is safe and effective for its intended use. I have also seen notified bodies that ask for change control history for a certain design and ask for supporting older version documents.

On the other hand, the FDA believes that the whole design history should be available to prevent such situations. It is believed that a whole DHF will give the design team the required information to avoid mistakes that occurred in older versions. I see the benefit of having both in place, especially that the Technical file is just a snapshot in time from the DHF. So If you have build your DHF properly, you can definetly have a technical file.

As Fady mentioned, essentially they have the same content, but the major difference is that the technical file has the current standards/specifications for the device and it does not take into consideration the design history. In my opinion, the DHF is an important tool in a validation/verification aspect, but this extra content may not be useful to lets say an individual that is just testing current specifications. The addition of the older historical data may cause confusion.

Chris

Agreeing with everyone, yes both of the files are useful and in some instances as mentioned above, one file is more useful than other.

But at the end of the day, both files are there for a reason. My personal opinion, I rather have both files on hand. If you need a quick overview of a project, do you really want to read through an entire file? While there are other instances in which you must have every possible detail of a project to make a final decision on continuation or budgets. Its not a personal opinion in this case as the question implies, we can come up with situations where one is better than the other. Its a matter of using the file to make the best decisions for your workplace and project. This or the other file is irrelevant, what matters is how you use those files in your job.

In my opinion, I think that the DHF is more useful. The reason for this is because this document is able to show a detailed and comprehensive design and development process until its release. Every change, every choice taken towards the design of the device, every mistake and every path taken is in the DHF and anyone that open the DHF is able to see how the device evolved from beginning to end. Every reference needed to make the device is in there, compared to the tech file in which it is just a snapshot of the design. It does not really tell you what changes where made and why, plus it does not contain any required SOP to follow. The DHF also, demonstrates that the design was developed in a coherent quality plan and a coherent set of requirements.

I have to defiantly agree with neb2, the DHF is a lot more useful than the design dossier since this file have detailed information bout the design, function, composition, use, claims and clinical evaluation of the medical device and it seem important but there a lot other information that is missing and I believe that the DHF have a lot of more crucial information that can be really useful for the medical device. We be able to learn a lot more using the DHF than using the design dossier.

I believe that the DHF is more useful than the Tech File/Design Dossier. The FDA is highly concerned with a company’s DHF because it involves everything from risk analysis to an end product where product specifications and customer needs are verified/validated, respectively. The files are very important in both the design and development process of creating a medical device from start to finish. However, if a DHF is put together correctly by the team, then a technical file, which is primarily a snapshot of the design, can certainly be placed into the DHF.

The DHF is a simply the collection of documents from the design to the development process. It is key file that contains all the design controls documentation and therefore it is a requirement by the FDA for the 510k submission. A technical file is very similar version to a DHF except that is a European version for the 510k. The technical file mostly explains that how is a particular product related or conforms to an applicable EU medical device regulations. Although, the technical file follows a format but it is less descriptive. The very big difference between the two documents is the need to submit a clinical evaluation report with the technical file. Both are very important documents and carry weightage in different regions.However the DHF is more detailed and thorough because of its existence from the initial stage.

DHF contains records necessary demonstrate that the design was developed in accordance with the approved design plan and requirement of the FDA’s design control.DHF contains detailed design plan,design input,design output,risk analysis,design verification and design validation and design transfer.Technical file describe the product at a point in time includes some elements of DHF like risk management documents and clinical data .TF addresses that product is MDD class I and class IIa or IIb while design dossier addresses product is classIII.DHF is more detailed than technical file,it is more useful.Newer EU regulatory guidance documents are moving TF/DD more in the direction of DHF

Tech File is easier, but DHF more useful. DHF : A compilation of records that contain the history of the design, such as validations, verification, qualifications, environmental testing, project plans, risk management activities, meeting minutes,design reviews etc. Often this will include all revisions of a procedure, drawings, etc. also Clinical Trails is very important.
FDA ensure safety and efficacy.
But Tech file Shows snap shot of design. Design Dossier equivalent to FDA's requirements for DMR+DHF

Tech File is required regardless of the class of device in the EU, whereas in the US the FDA requires a 510(k)for Class II and higher. Another difference is the Tech File as Dr. Simon mentioned in lecture, it has a set format. This format is referred to as the Summary Technical Documentation (STED). The STED format was created by the Global Harmonization Task Force (GHTF) know known as the International Medical Device Regulators Forum (IMDRF), in an effort to standardize medical device regulatory submissions on a global scale. The US, EU, Canada, Australia and Japan are currently either actively using STED or evaluating the format under pilot programs. Canadian regulators recommend STED formatting for Class III and IV Medical Device License (MDL) submissions, whereas the Japanese Pharmaceutical and Medical Devices Agency (PMDA) essentially requires STED formatting for market authorization applications. For the Tech file, requires going through verification and design validation first, whereas you just need to be through verification for the 510(k). As @reshamn notes a big difference is that one needs to submit a clinical evaluation report with the Tech file. Overall two different regulatory requirements, but neither clearly "better" practice than the other. It'll be interesting to see in the future if this changes and if so, what other countries adopt, or if the US or EU will end up adopting the other's.

greenlight.guru/blog/technical-file-vs-510-k-vs-design-history-file-dhf
emergogroup/blog/2016/10/what-sted-format-medical-device-technical-documentation