TaeWoong Medical Secures CE MDR Class III Certification

in Europe for Pulmonary Valve ‘PULSTA™’

TaeWoong Medical Co., Ltd., a specialized medical device company, announced that its self-developed pulmonary valve product, PULSTA™, has obtained certification under the European medical device regulation CE MDR (Medical Device Regulation).


On January 30, TaeWoong Medical held a formal certification award ceremony at its headquarters, where it received CE MDR Regulation (EU) 2017/745 certification from the global notified body BSI.


The certified product, PULSTA™, is a high-risk implantable medical device used in patients with complex cardiac conditions. By successfully obtaining Class III certification, which is subject to the most stringent evaluation standards in Europe, the product’s clinical effectiveness and safety have been verified in accordance with European regulatory requirements.


Compared to the former Medical Device Directive (MDD), CE MDR significantly strengthens requirements for clinical data as well as post-market surveillance (PMS). Despite ongoing certification bottlenecks for high-risk Class III devices across Europe, Taewoong Medical successfully completed the certification process through BSI, demonstrating its strong technological and regulatory capabilities.


A representative of Taewoong Medical stated,


“The CE MDR certification of PULSTA™ represents an essential gateway not only to the European market but also to other global markets that recognize or align with MDR standards. Through this achievement, we aim to provide safer and more innovative treatment options for patients and clinicians, while aggressively expanding our commercial presence across Europe.”

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