KTC Partners with ECM to Support Korean Medical Device Companies in European MDR Certification and Export
KTC Partners with ECM to Support Korean Medical Device Companies in European MDR Certification and Export
▲ Sungil Ahn, President of KTC (left) and Luca Bedonni, CEO of ECM (right), took a commemorative photo after signing the agreement.
Korea Testing and Certification institute (KTC) announced on the 4th that it has entered into a business agreement with Ente Certificazione Macchine srl (ECM) in Bologna, Italy, to facilitate the export activities of domestic medical device companies to Europe.
ECM is an Italian-based European Medical Device Regulation (MDR) certification organization responsible for conducting CE certification across various domains such as LVD, EMC, machinery, and equipment. It offers a wide array of services and support related to certification, encompassing testing and education.
MDR certification is a regulatory framework introduced in Europe to replace the previous Medical Device Directive (MDD) certification, aimed at enhancing the quality and safety of medical devices in the European market. This regulation has been in effect since 2021. However, due to the rigorous requirements associated with MDR certification, domestic medical device companies have encountered challenges spanning the entire product life cycle, from development to post-market surveillance, when entering the European market.
Through this agreement, KTC will collaborate with ECM not only in the domain of medical device MDR certification and support but also in areas such as IoT, medical device cybersecurity, software quality, batteries, electric vehicle chargers, wireless communication, and EMC certification. Moreover, they will extend their partnership into the hydrogen sector, covering hydrogen products and storage, and establish themselves as a designated testing facility for MDR and CE certification, thus gaining recognition for KTC's certification reports.
It is noteworthy that KTC, as the first testing institution in Korea to be registered as an MDR assessor, will be capable of offering service support throughout all certification procedures, except for the final technical document assessment during MDR certification. This signifies the initiation of the first-ever global certification collaboration in the hydrogen sector within Korea.
Through KTC's MDR certification assessment, companies can reduce the certification acquisition period by at least three months and lower transportation costs for sending test samples overseas. Furthermore, it resolves the communication challenges that have posed a significant obstacle when pursuing certification through foreign agencies and testing certification bodies.
In recent times, the medical device industry has been influenced by various technologies and trends, including the expansion of digital healthcare, the growth of wearable medical devices, the proliferation of telemedicine, advancements in AI and medical imaging technology, the increasing demand for personalized medicine, bolstered cybersecurity measures, and technological advancements driving global market competition. Consequently, it is anticipated that the competitiveness of domestic export companies will improve through MDR certification support agreements.
Sungil Ahn, the President of KTC, remarked, "The medical device industry is a future growth industry and holds national significance with expectations of sustained growth. We are committed to actively supporting the expansion of the medical device industry into Europe through proactive certification support."
In alignment with this vision, KTC plans to fortify not only its support through testing and evaluation for the European expansion of domestic companies but also its collaborative systems for MDR assessments, clinical evaluations, and the dissemination of the latest certification information and acquisition methods for the challenging European medical device market.
