E-Swin is delighted to announce that our products, E-Eye and tearstim®, have received the CE certificate under the new European Medical Device Regulation (MDR) 2017/745.
E-Swin is therefore one of the first IPL-manufacturers to achieve compliance with the new MDR requirements.
The new MDR certification is particularly significant as more than 80% of medical devices worldwide were not yet certified under MDR or still in the transition period (less than 3,500 CE certificates granted between 2020 and 2022). By obtaining this certification, E-SWIN ensures the compliance and safety of our devices, giving us a competitive advantage in the market.
Not only does the new MDR CE certificate guarantee the continuity of our supply chain, but it also impacts device registration in other countries outside of Europe. For instance, registration in India now requires the new MDR CE certificate. As a distributor of E-SWIN products, you can proudly assure your customers that our devices have achieved the new MDR CE certification, indicating their compliance, safety, and secured availability.
For any questions or further information, please reach out to us.
