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[Edaily Reporter Lee Jung-hoon] PRODIZEN, a company specializing in medical devices for cell therapy, announced on the 6th that it has passed a conformity assessment under the European Union Medical Device Regulation (EU MDR). 

The successful assessment recognizes the reliability of PRODIZEN’s products and quality management system amid increasingly stringent international medical device regulations. It also provides a stronger foundation for the company’s expansion into overseas markets.

The EU MDR, which replaced the EU’s former Medical Devices Directive (MDD), imposes enhanced requirements covering the entire medical device lifecycle. These include product safety and performance, quality management systems, risk management, clinical evaluation, and post-market surveillance. Due to its more rigorous assessment criteria, compliance with the MDR is regarded as an important indicator of a company’s quality competitiveness in the global medical device market.

Through this conformity assessment, PRODIZEN gained recognition for its quality management system and manufacturing capabilities, which meet international standards. Building on this achievement, the company plans to maintain its partnerships with existing overseas partners while expanding its presence in the European market.

A PRODIZEN representative said, “Passing the EU MDR conformity assessment confirms our quality management capabilities and technological competitiveness in line with global standards. We will continue to invest in quality management and research and development to provide products trusted by healthcare professionals worldwide and further strengthen our market competitiveness.”

Through continuous research and development, PRODIZEN has established proprietary technological capabilities in blood- and bone marrow-derived cell therapy medical devices, including PRP, GFC, and BMC products. The company has strengthened its product competitiveness based on patents obtained in Korea and other countries, while enhancing confidence in its product quality through global regulatory clearances and certifications, including U.S. FDA Class II clearance and European CE marking.

Leveraging its technological expertise and regulatory credentials, PRODIZEN has supplied products to markets across Asia, the Middle East, and Europe, steadily expanding its global network. Following the successful EU MDR conformity assessment, the company plans to further strengthen its quality management system in compliance with international regulatory standards and continue expanding its presence in the global medical device market.