Rokit Healthcare Receives CE MDR Certification for Organ Regeneration Medical Devices in Europe, Establishing a Foothold for Global Market Entry
Rokit Healthcare, a leading company specializing in organ regeneration, announced on the 1st that its organ regeneration platform medical device, the “Dr. INVIVO AI Regen Kit,” which utilizes artificial intelligence (AI) and bioprinting technology, has obtained CE MDR (Medical Device Regulation) certification. This certification is a more stringent European medical device certification compared to the previous MDD (Medical Device Directive).
The “Dr. INVIVO AI Regen Kit” has already obtained medical device approvals from the U.S. FDA, the Korean Ministry of Food and Drug Safety, and developing countries, and is being exported to ten countries, including the United States. With the newly acquired CE MDR certification, the company plans to accelerate its entry into more advanced countries, including those with existing contracts.
The CE MDR certification is an essential safety regulation for selling medical devices in Europe, applying stricter standards for safety, efficacy, and quality compared to the previous MDD CE certification. Medical devices that receive CE MDR certification can be sold in 31 countries, including the 27 member states of the European Union (EU), the European Economic Area (EEA), and Switzerland. Europe is the largest market in the field of regenerative medicine, with an annual growth rate of approximately 10%.
A company representative explained, “The certified medical device combines AI and bioprinting technology, enabling rapid procedures within one hour in the operating room, demonstrating higher regenerative treatment efficacy compared to conventional methods. It also represents an innovation in the field of regenerative medicine by providing lower medical costs.”
The “Dr. INVIVO AI Regen Kit” is utilized in innovative, patient-customized regenerative treatment technology. This product automatically recognizes the affected area through AI technology and instantly generates a bioprintable file. It then uses the patient’s own tissue for bioprinting to create a patch that can be implanted in the affected area. This regenerative treatment technology can be used to treat chronic wounds, such as diabetic foot ulcers (commonly known as ‘diabetic foot’), in the field of skin regeneration. Rokit Healthcare has conducted clinical research on diabetic foot treatment in multiple countries, proving its safety and efficacy, with results published in five SCI-grade international journals, demonstrating its scientific success and global commercialization.
Seok-Hwan You, CEO of Rokit Healthcare, stated, “The CE MDR certification will serve as a foothold for entry into the European market as well as the global market, allowing us to provide cutting-edge medical services to more patients. We will continue to advance AI-based regenerative medicine kits and bioprinting technology, expand the application areas of regenerative treatment, and strive to become a global leader in the field of regenerative medicine.”
