February. 03, 2023—Carilex Inc. is a multinational corporation specializing in designing and manufacturing medical devices for wound care. Their product range includes therapeutic support surfaces and negative pressure wound therapy systems. Recently, the company announced the successful review and acquisition of the class IIa CE Mark for its Alternating Pressure Air Mattress products from the EU Notified Body DNV, in compliance with the Medical Device Regulation (MDR). This certification underscores Carilex's commitment to maintaining high-quality and safety standards in designing and manufacturing alternating air mattress products.

The MDR, which replaces the Medical Devices Directive (MDD), sets forth new regulations governing the manufacturing and distribution of medical devices in Europe. It imposes more rigorous and binding requirements than the MDD, emphasizing product safety, clinical data, clinical evaluations, and post-market surveillance. The European Commission has recently proposed a delay in transitioning to the MDR due to limited Notified Body capacity and the need for manufacturers to comply with the stringent MDR requirements. Nevertheless, as one of the earlier global manufacturers to obtain CE marking under the MDR, Carilex has established a solid foundation for expanding into the global medical device market. Furthermore, compliance with the EU MDR is necessary not only for the European Union market but also for selling medical devices in the United Kingdom, the Middle East, and Southeast Asia.

During the application process for the CE MDR certificate, Carilex successfully established Carilex Medical Technologies GmbH, a subsidiary in Germany. This new subsidiary will facilitate advantageous business operations and enhance competitiveness in the European market. Andy Cheng, the CEO of Carilex, stated, "Moreover, we can strengthen our local business network and establish robust relationships with partners by offering comprehensive, high-quality, and responsive services."