Dutch Firm TheOTCLab Gets EU MDR Approval For Dr. Yglo OTC Wart Device
Executive Summary
Amsterdam-based TheOTCLab has received an EU CE mark for its new wart and verruca OTC freezing device Dr. Yglo. The firm plans to launch the product in Europe in Italy, Portugal, Estonia, Latvia, and Lithuania, and will separately look to take it further afield to the US and South Africa.
Amsterdam-based self-care company TheOTCLab Healthcare B.V. has received a European Union Medical Device Regulation certification for its latest OTC product, Dr. Yglo.
Describing Dr. Yglo as an innovative freeze treatment for warts and verrucas, TheOTClab scored a CE mark for the product after meeting the necessary conformity assessments, which means it can be marketed across the EU as an OTC device.
Dr. Yglo’s “unique precision tip” freezes warts or verrucas at their core, while avoiding the surrounding healthy skin, resulting in a “more pain-free application,” the company explained.
“About 15% of the population suffers from warts once in their life, mainly children,” commented CEO Albert Swane. “We believe that with our latest innovation we can instantly freeze warts easily and effectively and that Dr. Yglo offers a solution that meets the needs of our customers.”
The firm says it plans to launch this year in Italy, Portugal, Estonia, Latvia, Lithuania. With Dr. Yglo already cleared by the Food and Drug Administration as an OTC device, a US launch is also planned, with a separate roll-out also scheduled for South Africa.
TheOTCLab will work together with local partners and distributors with the “right level of knowledge and expertise” in their markets, which the firm said will “help in determining the right sales channels such as pharmacies and drugstores.”
Informed by this local expertise, TheOTCLab said it will also tailor marketing strategies, using a mix of various marketing tools such as ATL advertising, in-store activities and promotions and social media.