Mediana, Patient Monitoring Device-Central Patient Monitoring System 'European CE MDR' Certification Acquired

Mediana, a medical device and AI medical solution specialist, announced on the 14th that all of its Patient Monitor Device (PMD) models and Central Monitoring System (CMS) have received European CE MDR (Medical Device Regulation) certification.

CE MDR is a regulatory requirement that must be met for medical device distribution within the European Union (EU), and applies stronger safety, quality, and performance standards than the existing CE MDD (Medical Device Directive). This certification ensures product reliability and market competitiveness, and enables official sales within Europe.

This certification establishes the basis for Mediana to officially supply PMD and CMS products throughout Europe, including the 27 EU countries, the UK, Switzerland, Turkey and the European Economic Area (EEA).

Mediana was the first company in Korea to obtain CE MDR certification for its automated external defibrillator (AED), thereby laying the foundation for its entry into the European market. This additional certification of PMD and CMS products is considered a strategic move to strengthen its position in the European market.

The CMS that has recently been certified is one of Mediana’s core solutions, a software that can monitor the vital signs of multiple patients in a hospital in real time. It is expected to be in demand from medical institutions in Europe as it can help medical staff respond quickly and contribute to improving work efficiency and patient safety. Mediana is also focusing on improving the functions of CMS and improving system interconnectivity in cooperation with its affiliate Selvas AI.

Mediana CEO Kang Dong-won said, “We have already achieved meaningful results in the European market by being the first in Korea to receive CE MDR certification for AED products,” and “We plan to further accelerate the expansion of our customer base in the European medical device market through this patient monitoring device and CMS certification.” He added, “We are also preparing for CE MDR certification for our high-end external defibrillator (Monitor/Defibrillator) to enter the European emergency medical market in the future.”

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