Going International Before Obtaining Your CE-MARK

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A review of the recent developments made by Clarteis, an innovative company in the area of dermatology.


Typically, medical device start-ups develop a product in connection with their end users (most often on their own, unfortunately), they then raise funds, adjust the product from prototype to an industrialized device that is safe for patients, go through the quality and regulatory processes and then they start thinking…


« Oh, now that the product is CE-marked, how and where should we sell our device ? »


Did I forget to mention that because they have a high opinion of their device and engineers, they think it will sell without any clinical justification, without any marketing tools, and without the company having a good understanding of the international markets and their differences? Most of the independent consultants I’ve spoken to all have experience with these types of companies, and a lot of them end up failing to sell their device on a large scale.


Luckily, there are companies that think ahead and understand what it takes to sell a device in international markets. An example I have in mind is Clarteis, a company that has developed an exciting technology for dermatologists for the treatment of psoriasis and vitiligo. The company is in the process of establishing its quality management system and should obtain the CE-mark for its device in the summer of 2016. It took the bull by the horns to ensure they could sell their device as early as fall 2015 when it started approaching distributors with its technology and getting market feedback. This allowed the company to take into consideration the challenges in different countries, the regions to focus on based on standard practice in dermatology and how to adapt its strategy and focus. Today, the company is set for a tremendous start as it is already engaged in long discussions with various distributors in different regions who are willing to commit once the CE-mark is obtained.


This is certainly the best strategy, although it can sometimes create frustration with distributors who want a device that they can sell immediately with clinical data to support it. Nevertheless it does eliminate the time required to identify the right business partners and the subsequent contractual negotiations.


Mathieu Charleux, Associate Partner.

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