Ente Certificazione Machine (European Notified Body n.1282) and KTC (Korea Testing Certification institute) are preparing to sign an important Memorandum of Understanding (MoU) to collaborate in the safety and conformity assessment of products, machinery and medical devices destined for the market European and Korean

Trade relations between the European and South Korean markets are strengthened.

On Monday 4 September 2023, the President of KTC Sung-il Ahn – former Deputy Minister of International Trade and Legal Affairs in Korea, and Luca Bedonni – Sole Director of ECM, will sign the Memorandum of Understanding which will de facto sanction the collaboration between the two organisms.

In addition to the ECM team and the KTC delegation, the MoU signing ceremony will see the participation of numerous institutional personalities from both Korea and the Emilia region, as well as representatives of trade associations and the academic world.

THE INTERNATIONAL CONTEXT

Following the entry into force of Regulation (EU) 2017/745 (MDR), medical devices can only be placed on the EU market after a rigorous conformity assessment process conducted by a European notified body designated under the MDR. With the intention of encouraging exports to the EU market, the Korean government has put in place a series of measures to support medical device manufacturers in complying with the stringent requirements of the MDR.

KTC, the state testing and certification body of South Korea, therefore turned to ECM as European Notified Body n. 1282 for Regulation (EU) 2017/745, to give life to a collaboration aimed at satisfying the growing demand for EU certification for medical devices produced in Korea and destined for the European market.

Ente Certificazione Macchine will become a reference European notified body for Korean manufacturers who wish to undertake the EU certification process pursuant to Regulation (EU) 2017/745 to place their medical devices on the EU market. KTC, a state body authorized to issue the KC (Korean Certification), essential for trading on the Korean market, will vice versa become the point of reference for European companies which, turning to ECM, wish to place their products on the Korean market.

As already happened with UL in the electrification sector for the American market, ECM and KTC are preparing to give life to this important international collaboration, which further consolidates the technical-commercial relations between Europe and South Korea. In addition to medical devices, the agreement between the two bodies will also extend to safety and compliance checks of lithium batteries and other products in key sectors, which in order to be marketed in Europe must be CE marked in compliance with the reference standards.

Download the official press release here