Hi All,

I would agree that devices would be easier to get approved in the EU for a number of reasons. The main reason being that the classification is purely based on a checklist and risk. This allows a device to be designed and the company to know exactly how the device will be classified and they can simply follow those regulations. In the USA, this process is quite a bit more difficult as the class system can vary quite a bit more, making it more difficult to know exactly how a device will be classified. This is due to the classification system depending on more than simply just risk.
Looking forward to hear what others think and their experiences.

-Andrew Nashed

Hi all,

From my limited experience, it is indeed a lot easier to obtain EU approval prior to US approval. The main reason in my opinion is that in EU the manufacturer is not dealing directly with the regulatory agency. The manufacturer is dealing with a notified body which is contracted to review the on behalf of the EU competent authority. There are so many Notified bodies available in the market who are competing for business since they charge manufacturers with substantial fees to review the technical dossier. This allows for a faster review process and more collaborative work. On the other hand, As andrew have mentioned, the EU regulations contains checklists and do not leave much room for manufacturers' interpretation. The FDA reviewers are the sole decision makers for the interpretation of the regulations.

- Fady Khalla

Per my personal experience, the current company I worked for used the same approach in receiving approval by the EU and obtaining the CE Mark before getting FDA approval. In general I believe it was easier because the device that my company is working is a Point of Care Diagnostic Testing device which would fall under the IVD Directive 98/79/EC and hence its classification would either be a List A or List B. This classification would be based off of the Essential Requirements Checklist. Whereas, when going through the 510k process for a Class II medical device with PMA for the FDA, clinical data must also be presented, as well as a means of showing efficacy, which I believe is the major difference between the FDA and EU. The FDA puts a strong emphasis on efficacy whereas the EU looks at the risk.

It is easier to get devices approved in the EU because it requires less data and evidence compared to FDA. For example, FDA would require an actual study based on a big sample where in EU, you may be able to get it approved on pilot data. Other factors include that FDA is a directly under the government and in EU a private company is chosen and they independently do their own vetting on the devices. As well as their device classification, timelines, process, cost, and results differ greatly. EU results gives market access vs FDA gives exempt, clearance, or limited clearance even if the device is approved. So If I were to bring a device on the market, I would first launch the device in EU for better business and later in the FDA because of the strict rules and regulations and getting a partial result even after following the rules and regulations.

Hi All,

I was thinking of one way that getting a medical device approved in the EU may be more difficult than in the USA and only thought of one: It may be difficult for a small, US based company to have an authorized representative. Small companies may not be able to afford or obtain an Authorized Representative in the EU. Even though there are private companies who acts an authorized representative, it seems like a difficult process for a smaller company without as much funding and no European base to begin.

Has anyone had any experience in finding an authorized representative in the EU?

-Andrew Nashed

From what I learned during the lecture, I think it is easier for a medical device to be approved. The directives does not give you a "one size fits all approach" instead there are many ways,the conformity assessment route, in which not all articles in the directive apply to the device and there are different route choices that can be applied to demonstrate compliance to the MDD and the essential requirements.Thus giving a fastest route for approval and CE marking or even a route that is cost effective that will also get approved.
Also the classification of the product is easier, the EU classifies medical device based on risk only and the essential requirements check list helps determine classification. Also, clinical data requirements, as specified by tn58, for CE marking arises from the requirement to demonstrate that a device is safe, that it performs as intended, and that risks are acceptable when weighed against the benefits of the device. For low to medium risk devices, clinical data can be presented as a compilation of relevant scientific literature available on the intended purpose of the device and the techniques employed that can demonstrate safety and performance. For high risk devices, clinical trials are required but it does not required a prospective, randomized controlled, adequately powered clinical trials involving hundreds of patients like the FDA requires, so long the device demonstrate safety and it performs in a manner consistent with the intended use. Resulting in less time and money spent for a CE mark in order to put the device to the market.
Another big plus that EU regulation offers is the fact that if something is changed to the tech file, it must be reported to the Notified Body and if they think is something of concern they request the tech file, but the company can still start selling the device on the market compared to the FDA that if something changes, a whole new 510K or PMA supplement must be submitted which may need new clinical trials and the device cannot be sell in the market.

I do agree that the EU has an easier system to approve the medical devices than the FDA approval. Initially all the countries in Europe had their respective rules and they all had to give up their individual rights for approving medical devices to be able to join the EU. With this combination of rules, the various countries came to an agreement with all of the countries approval. However, the FDA was created based on products that were made with false labeling and ultimately harming people. And over time, regulation was put in place as more complex devices required to have additional efficacy testing to ensure the safety of the United States. And with that seeing that the FDA works to check for safety and efficacy while the EU identifies its devices based on the risk level.

Hi all,

As everyone mentioned above, it is easier to have devices approved in the EU, the main reason is that the regulatory aspect is not as strict when compared to the US regulatory agencies. In addition, the FDA was created based on tragedies and incidents that compromised peoples health and lives, thus adjusting its regulation while the European Union regulatory agencies base on the levels of risk for the device.

Chris

After listening to the lecture, it is clear that it is easier to get devices approved in the EU for several reasons. The EU bases their classification on an essential requirements checklist and on risk. In the United States, regulation by the FDA was created because products were harming people due to improper labeling. Thus, as per the FDA, testing on the medical devices is required to guarantee product safety for customers. While the FDA checks for effectiveness and safety, the EU classifies its medical devices on risk level. In the United States, the process of classifying a device is not as simple because the process involves a class system and it is not always easy to decide what the device belongs to. Medical devices have to go through processes such as the 510k, which is submitted by the medical device manufacturer for clearance, and also premarket approval prior to marketing. All of this involves clinical studies and the gathering of data in order to show efficacy. In the EU, a company is chosen to do testing on the devices, while the FDA is under the government. Thus, less data is required to prove how effective the device is. It seems like one can say that the regulatory side of the entire process in the EU is not as strict as the United States’ process. Overall, the FDA cares very much about efficacy and the EU cares about risk.

I would tend to say that device approval is easier in the EU because it is faster. And it is faster because it is simpler and is based on a checklist that leaves little room for gray area and saves time by eliminating the need for further discussion. Furthermore, the EU requires that clinical safety be proven (for Class IIa, IIb, & III devices) with clinical evidence (which may or may not be a clinical trial) while the FDA requires a clinical trial itself, which can take years to complete.
This table from an article on Science Direct nicely lays out a comparison of the two approval processes:

Original Article:
http://www.sciencedirect.com/science/article/pii/S2452302X16300638

Hey I agree that this is true but it also makes me worry about products coming from the EU. Due to the fact that the process is quicker and easier are product equally safe? I can't imagine shortened/non-existent clinical trials for devices and drugs.

So shouldn't the EU also have systems in place to prevent tragedies? Shouldn't they learn from the FDA and take precaution? I personally think that the FDA might prohibit research and great products to coming to market quickly but at least they will be safe. If always been weary about the EU device agencies.

I believe the main difference is that the EU focuses on the risk as Dr. Simon mentioned in his lecture. Each classification based on the medical device directive is based on risk, so to an extent, the EU is taking notice of the potential dangers of the device. However, I believe most device companies would provide the research of showing the devices safety and efficiency even if it may not be required by the EU. Most medical device companies, who spend millions on research & development would want to sell their products in the USA, which is the #1 consumer in med devices where they could make the most money, so they would have to go through the 510k/PMA process provided by the FDA.

Ideally they should have a set system or a method to prevent these tragedies. My only exposure with respect Regulatory agencies within the European union and the US market is within a cosmetic aspect. I know for sure that there are specific chemicals that are banned or they are gradually being removed from the European market but are still implemented within the US market and vice versa. The standards or long term effects of particular cosmetic ingredients may be view differently per regulatory body.

Chris