Design control is not required in EU, but I would say it is very helpful to have it, EU do have the Design Dossier/ Technical Files which king off go along with Design Control but it is not the same document as design control. Design control is very important document to have it if it required by the EU medical device regulation agency or not because you wana catch any problem possibly the product might have before it launch in the market, because if someone get hurt by your product your company will loose a lot of money. So it is better to invest a little more time and make a DHF. So if we talk about comparing two philosophies I would say having the Design Controls is very important if some companies think it is not necessary step and we do not do it because it is not required then that companies will end up hurting it's business at some point. And their is only the Pros to this their is no Cons, having everything documented DHF can help if something happen in the future and their is some improvement to make.

If one desires to reproduce the device then the DHF will be the way to go. For a summary I believe the tech file would be more useful. The tech file might eliminate the cumbersome information that is not required at the time of approval which may lead to a quicker approval.

Being that the DHF has more detailed information from day one to production, all changes to the design and device flaws will be captured in this file. This will prevent similar mistakes from occurring if there should be an improvement to the device in the near future. Should a device flaw be found I believe the DHF would be a better file to have than a tech file which means less expenditure to rectify the issue.

This is an interesting question! I agree with most of the participants that depending on the device classification, EU regulatory looks at the device development in the Tech File. While, in the US, Design Controls such as DHF and DMR are required by the notified bodies such as FDA. It is beneficial for the medical device companies in the US markets to have records such as DMR and DHRs as part of the design controls because it contains the history of how exactly the product or lot was manufactured. These records are very useful in the event of the investigation required as part of the product recall. On the other hand, in the EU market, Tech files are also useful, but it will be very hard and time consuming to exactly identify the root cause of the issues as there is no traceability at each step. All in all, both philosophies has design controls, however in the US market there are more stringent requirements for the medical device industry.

This is an interesting question. I agree with most of the participants that depending on the device classification, EU regulatory looks at the device development in the Tech File. While, in the US, Design Controls such as DHF and DMR are required by the notified bodies such as FDA. It is beneficial for the medical device companies in the US markets to have records such as DMR and DHRs as part of the design controls because it contains the history of how exactly the product or lot was manufactured. These records are very useful in the event of the investigation required as part of the product recall. On the other hand, in the EU market, Tech files are also useful, but it will be very hard and time consuming to exactly identify the root cause of the issues as there is no traceability at each step. All in all, both philosophies has design controls, however in the US market there are more stringent requirements for the medical device industry.

I think maintaining a DHF is necessary and beneficial from a company or device designer point of view but not for device approval. Every product goes through several iterations, changes and modifications before arriving at the final design. As the product is approved or submitted for approval based on the final model of the design, in favor of the EU regulatory style of philosophy, I think the device design specifications on the final design would be appropriate to make a decision on whether the device meets the requirements or not. Otherwise in an ideal situation, a regulatory body should not need the design history from its 'first prototype' to approve the 'final design'.

Design Controls are not needed in the EU regulations, because they view a "snapshot" of that given point in time of the life of the device, they are searching for issues that could be present. The Technical File and Design Dossier is equivalent to the US's DMR, it looks at the product's development process. It is not required in the EU to include a DHF but a company can still implement it. In terms of which is best, i believe it is a good idea to include the DHF for the EU, this is because it keeps track of all design processes, and this can be helpful when attempting to review old decisions of the product's design once it has been passed along to production. It serves a way for the company to learn from their mistakes and view where along the design process decisions were made; this allows companies to search for a solution. The Tech File and Design Dossier already includes a design control procedure so by including a DHF, it wouldn't hurt the company but make it easier in the future. As another user mentioned before, Information is best written to reference them, information cannot live in the mind of the creator because it can be forgotten and lost. The limitation for the DHF would be that it is a frozen file and cannot be edited, that is what the DMR is for (Live document), but the DHF has it's importance for the design process.

Design controls are certainly enforced throughout the development process of medical devices in the EU, the real question is whether or not they are sufficient enough to yield safe and effective medical devices to market. Design controls fall under the device history file (DHF) when developing a medical device in the US, but the same does not go for the technical file of a EU medical device. The main difference between the DHF and the technical file is that the technical file is less regulated in terms of having a medical device conform to meet the essential requirements. This "conformity assessment" of EU devices are what allows the manufacturers to decide their safety/efficacy standards by allowing their devices to be conducted by an independent commercial organization rather than a regulatory agency.

A technical file is said to be identical to a 510(k) in the sense that it aims to prove that a device meets the standards of a medical device's regulations, but unlike a 510(k) it does not require a clinical evaluation report. This means that an EU Class I or IIa/b medical device does not have to include its clinical investigation, risk, or post-market surveillance. As a result, medical devices in the EU are being brought to market at a quicker pace than in the US, which for example, can be represented by a 1-3 year delay in the development of drug-eluting stents in the US compared to the EU. Low to medium-risk devices such as Class I and II EU devices are brought to conformity by what's called a "literature route", which only requires bench-testing, animal testing, and pre-existing clinical data from published studies in order for the device to enter the market. Furthermore, high-risk devices that do require clinical data undergo a more expedited form of clinical testing. US clinical testing for Class III devices includes a randomized trial of hundreds of patients while EU trials consist of non-randomized (single arm) trials of a maximum 100 patients. Simply put, the philosophies between the EU and the US can be stated as the EU seems to produce more medical devices than the US, but the US puts more thought and care into their devices before releasing them to market. Some might say that the EU focuses on the quantity of medical devices developed while the US prioritizes quality.

Is it possible that the US puts too much concern and scrutiny into medical devices attempting to enter market? Is there a significant difference between medical device recalls in the EU vs. the US? Assuming the EU and the US have a similar track record of medical device recalls, does that imply that the design control standards should change for either side or remain the same? Why or why not?

Reference:
(1) "Medical Device Development: US and EU Differences" (2006) Applied Clinical Trials
(2) Speer, John, "Design History File vs. 510(k) vs. Technical File: What Do Medical Device Developers Need to Know?" (Nov. 2017) Medical Device and Diagnostic Industry

The regulations in the USA vs EU are stricter in terms of documentation. With that being said it seems that the FDA tends to expatriate the companies with documentation where EU is lenient. However, in terms of actual processes I believe Design Controls should be applied to every country that works in the medical device industry. These controls help to keep users and patients safe that’s as simple as it can be put. I raise a question. With less regulatory rules do products still have excellent quality? With less controls do more medical devices become quicker to produce then the US?

The quality of a product does not necessarily depend on how many regulatory rules there are. One can require hundreds of rules on a device yet produce a very low quality product. I believe that the steps and precautions taken during production of a device is the ruling factor in if it is of high quality or not.

With the EU having less rules, the manufacturing of the device is more prone to mistakes than if there were more regulatory rules. For example, say we are producing the same medical device in the US and the EU. We are manufacturing a device where all the products are purchased from Home Depot and ACE Hardware. But after some research, we realize that Lowe's provides all the materials needed and we start purchasing materials from this one store. This change in supplier would be recorded in the DMR in the US but not in the EU. This notation in change of supplier keeps the company updated and ready to find a new supplier: in case Lowe's were to go out of business, they can always revert back to purchasing their materials from Home Depot and ACE Hardware. But this information would not be readily available in the EU and would be more of a hassle to find a new supplier since nothing was written down.

I want to update your claim on the EU classification requirements. Your reference article is on MDD, Medical Device Direction but it was replaced by the MDR, Medical Device Regulation, last year. All devices now require a post-market surveillance report which includes sections on risk, clinical investigations, and trends on post-market data. So although the original submission of the technical file may only require literature route but to keep conformity, the information I listed, is still required.

In regards to your question about the scrutiny of medical devices entering the marketing, I believe that in the US, it overly-scrutinized. I understand why there is a concern over the safety of the product and that for new products similar to ones already on the market, there is more leniency. But these government agencies ask for so many documents and so many tests. For old companies, its much easier to comply but with small ones with limited resources, it becomes a barrier for entry.

If you were to make a device in the EU, it would be subject not to the regulatory documents required in the US but to those required in the EU. Every country has its regulating body that ensures the safety of its citizens. The EU is notably less strict than the US, and requires less thorough documentation, validation, and testing. If you wanted to sell the product in the US on US soil however, you would need to adhere to the regulating body of both the EU and US. To sell in the US you need FDA approval.

As jz365 has mentioned, the EU has a different regulatory body than the US. For the EU, no design controls are not "needed". Yet, that will limit your market size because it is needed in the US. I would recommend adhering to whichever regulatory body is more strict because it can help ensure you have a safer product for the masses, and it will allow you to sell to different markets in the future if you want (assuming the all the documents of the less strict are required by the stricter regulatory body).

Interestingly, as a brand new development which I have not had time to update for the course, Design Controls are now in fact required virtually everywhere in the world. The new EU Medical Device Regulation (MDR) specifically looks for a quality system that follows ISO 13485:2016. If you look at ISO 13485:2016 (which itself is still very new), you will see it is virtually a 95% copy of 21 CFR 820, and under the product realization sections you have.... guess what? Design Controls.

So now, any regulatory system, in any country, that requires or accepts the use of ISO 13845:2016 as part of its process now requires Design Controls. It's a big deal.

Although a DHF is not required in the EU, design controls are still necessary. There are documents that are necessary when designing medical devices in the EU. These include the technical file, the declaration of conformity, the design dossier, and NB decisions and reports or certificates. Without these documents, you can have serious issues when an audit occurs. 

With the ISO Adopting the Design Control, the EU regulatory which follows ISO regulation will have to accept ISO 13485:2016 for Design Control into their Development process of a Device. 

That being said, they will definitely have to look into using or adopting the DHF document since the Design controls gives a detailed specification of Initiating, planning and executing a Medical Device. Having the Tech File or the Design Dossier which is not as Comprehensive as the DHF-which contains every details of the device, it will not be a good way to go on Developing a Medical Device since safety is the major priority, well detailed documentation of the product will be needed.

Another reason they will need to adopt the use of the DHF, will be that whatever product that is to be made and put on the market, will need to be scrutinized by ISO which will want everything about the product document and sad to say the Tech file doesn't have this and it's more like the Device Master Record (DMR). 

In a nutshell, Device development in the EU can no longer be looked at as a snapshot but with the Design Control in place, this will need to be looked into from beginning to end and also track every rationale at each step which the DHF does. This will help for a more quality and safer Device produced and not having to make a call back to redesign due to issues discovered by the customers.