Why the CE Mark Matters
Product and service development are at the heart of customer satisfaction. In an ideal world it all begins with someone (say, person A) identifying someone else's need (say, person B). This need, although sometimes not so obvious, is transformed into a set of feasible configurations, which in turn result in a physical product or service. There is then a free exchange between person A and person B: the former receiving a product that will benefit them or their customers, the latter increasing their revenue. Pretty simple, right? The short answer is yes. That is, it's a pretty simple system if we choose to ignore all the steps that happen between development and deployment. But we are diligent people, we can't just ignore the intermediate steps. As a matter of fact, the difference between success and failure happens in these steps. This is particularly true in the medical device industry.
Given the current global situation, you've probably heard terms (perhaps even for the first time) such as medical device, FDA, MDR, clinical trials, and so on. According to Europe's Medical Device Regulation (MDR), a medical device is defined as
Any instrument, appliance, software, implant, reagent, material or other article intended by the manufacturer to be used, alone or in combination, for human beings for [...] specific medical purposes
For medical devices, it is clear that the "manufacturer" is person A (the one that identifies a need) and person B is the one that has a need, in this case a "specific medical purpose". A crucial piece of the puzzle is the regulatory framework, without which market access is unachievable if the market in question is regulated.
And in comes the CE Mark. This stamp of approval, symbolized by the CE logo as seen on the left, stands for "conformité européenne" (European conformity). The CE mark is affixed to products, for the sake of this article, medical devices, that have successfully satisfied the requirements of th e MDR. A medical device can therefore only be placed on the European Union market without the CE mark. In general, each country or region, be it the USA or Japan, has its own set of regulations and its CE mark equivalent. The most popular being the proverbial "FDA Approved" stamp. So now you may wonder why I'm choosing to focus on the CE Mark instead of the FDA. Why should one matter more than the other? Before I explain my choice, it is important to note that having the CE mark does not allow you to sell in the USA. Similarly, FDA approval does not give access to the European Union market.
Choosing which regulation to follow becomes important in an unregulated (or partly regulated) market. For example, there are no specific medical device regulations or regulatory bodies in Zimbabwe. So if you wish to sell a medical device in Zimbabwe you will have to ask yourself, "how do I go about it"? Sell the medical device without any form of approval? You could. But that isn't good practice. Your best option is to either get your device CE marked, or FDA approved. The point I am trying to make is this: when a market is unregulated, as is the case for most developing countries, the most credible way to place your device on that market is to adhere to an international regulation. This is obviously not ideal, but until each country/region puts in place its own regulations and regulatory processes, this is what we are stuck with.
Now, back to why CE and not FDA. In my opinion, the short and simple answer lies in time, effort/complexity and money. Let's look at the Zimbabwean example again. You are a startup in Zimbabwe and you've come up with an amazing device that will help benefit the nation's healthcare system. Your prototypes showed promising results and you have manufactured a small batch of production units, ready to be shipped to your first clients. However, you are slightly concerned that you haven't fully ascertained the safety and effectiveness of your device, although it is fully functional. You decide to comply with an international regulation to ensure that your clients feel like they are using a reliable device, and to promote quality within your organization. The only problem is that you don't know where to start. One of the engineers decides to do a bit of research (typical engineers, right?) and finds some interesting information from a globally reputable regulatory consultancy:
FDA approval for medium risk devices take between 6 to 9 months while CE marking takes 3 to 6 months;
FDA approval for high risk devices take between 18 to 30 months while CE marking takes 6 to 12 months;
The validity period of an FDA approved device is infinite, while CE marking certificates are renewed every 3 years;
The complexity of the regulatory registration process is considerably higher for FDA approval compared to CE marking (4 out 5 for the former, 3 out of 5 for the latter, on a scale of 1 to 5);
The estimated cost of achieving approval is much higher for FDA approval than for the CE mark due to the former's review cycles taking up to three times longer;
It is a bit clear now that from a project management point of view, going for CE marking is the more feasible option, despite the fact that CE certificates need to be renewed every 3 years. The question then becomes a matter of which option gets you to the market more quickly and more effectively.
What about a partly regulated market such as South Africa? The approach is a combination of following both the processes laid out by the South African Health Products Regulatory Authority (SAHPRA) and international regulations such as the European MDR. Despite the great strides made by SAHPRA since its establishment in 2017, it does not yet provide product approvals. In other words, medical devices do not get a "SAHPRA approved" mark like with CE. Instead, for medical device manufacturers, SAHPRA approval means that they are given an establishment license. One of the requirements for receiving this license is to have a CE certificate. Again, this is not ideal but it ensures that the products that are manufactured in South Africa, although such home-grown products only comprise about 10% of the medical device market, are reliable and of the highest standard.
So, what does this mean going forward? Two things should be highlighted. Firstly, as was made evident by the Zimbabwean example, the African market is heavily reliant on international regulations. This has a double-sided effect on the African market. On one hand, the international regulations are reliable and ensure end-user safety, on the other hand the cost of achieving CE marking (or FDA for that matter) is a financial burden and barrier to African manufacturers. South Africa is a great example of what the African market could look like in the near-future, assuming a high level of optimism. One way to implement a better system is to charge international manufacturers a registration fee to get a "CA Mark" (conformité africaine - following suit from conformité européenne) and place their products on the African markets. Similarly, African companies could be charged a lesser fee to also achieve market access. As a result, more African companies would have a fighting chance in the medtech market that is overwhelmingly dominated by international giants. But for now, get your medical device CE marked (and SAHPRA approved if you are in South Africa).