MDR Certification Body ECM, Visits KTC…"First Achievement for Domestic Testing Institution"
- Achievement within 6 Months of Signing Agreement... Expectations for Increased Vitality in European Expansion of Domestic Medical Device Companies
- Facility Tours, Maintenance of MDR Auditor Qualifications, and Additional Discussions... Prospects for Enhanced Export Competitiveness
▲A photo of the meeting between the delegation from the European medical device MDR certification body ECM and KTC officials for business discussions.
The Korea Testing and Research Institute for Machinery and Electronics (hereafter KTC, Director An Sung-il) announced that a delegation from the European medical device MDR certification body ECM* visited KTC, making it the first domestic testing and certification institution to receive such a visit.
The visit took place on the 21st at 10:30 a.m. in the executive conference room on the 1st floor of KTC's Gunpo headquarters, attended by Director An Sung-il, Bio Business Division Director Kwon O-ryun, and Electronics Medical Center Director Nam Ki-il, among others, along with four members of the ECM delegation.
The ECM delegation included Luca Bedonni, President, Andrea Cavagnini, Asia-Pacific Regional Director (based in Shanghai, China), Kang Myung-soo, Head of Korean Branch, and Lee Song-hee, responsible for the Korean Branch.
ECM is a European medical device MDR certification body based in Italy. KTC became the first domestic testing institution to be registered as an MDR* auditor and designated test site through a business agreement with ECM signed on September 4, 2023, in Bologna, Italy.
KTC provides support for all certification procedures during MDR certification audits (excluding final technical document review and registration), actively assisting domestic medical device companies facing difficulties in European expansion due to recent MDR certification regulations tightening.
Following the business agreement with ECM, KTC has consistently pursued practical discussions to establish a rapid European certification support system in the domestic medical device field, solidifying collaboration for business expansion and activation. As a result, within just six months of signing the agreement, KTC achieved the remarkable feat of hosting the first visit from an MDR certification body delegation among domestic testing institutions.
During the visit of the ECM delegation, KTC conducted practical discussions to provide rapid support for KTC's MDR certification project and strengthen cooperation.
Detailed discussion topics included ▲collaboration for expedited progress of MDR certification for domestic medical device companies ▲organization of MDR certification seminars for domestic medical device manufacturers (covering practical education on MDR certification regulations and technical document preparation) ▲practical discussions on maintaining MDR auditor qualifications and personnel exchange ▲discussions on other fields such as IoT, medical device cybersecurity, and software quality.
▲A group photo commemorating the visit of the delegation from the European medical device MDR certification body ECM to KTC. (From the third person from the left: Luca Bedonni, President of ECM; An Sung-il, Director of KTC, etc.)
Furthermore, KTC plans to hold MDR certification seminars for companies aiming to export to Europe in the second half of this year, providing guidance on acquiring the latest certification information and methods. They also plan to gradually expand their global network related to MDR certification, including signing an MOU with three EC* institutions in Slovakia within this year.
Moreover, leveraging the recently established Sleep Industry Promotion Center (established in March of this year) as a hub, KTC plans to enhance its support system for clinical evaluations and provide the latest clinical certification information for domestic medical device companies facing high barriers to entry into the European market. It is expected that this will enhance the export competitiveness of domestic companies seeking MDR certification.
Director An Sung-il stated, "To secure global market leadership in the medical device industry, which is both a future growth industry and a key national industry, we will actively deploy certification support measures," further expressing, "We will spare no effort to enhance the export competitiveness of domestic companies and drive the European expansion of the medical device industry."
