MEDA Co., Ltd. is proud to announce that it has received EU Medical Device Regulation (MDR) certification for its Ultrasonic A/B Scanner for Ophthalmology and Bladder Scanner products, signifying that the company now has the newest key to EU market and demonstrating full recognition for its robust quality management system.

MEDA has always placed a high priority on building its quality management system since its establishment and made it more efficient and effective by its ongoing update and improvement on the system. This has helped the company easily obtain certifications from competent authorities across EU, U.S, Japan, South Korea, etc., underlying great significance MEDA has attached to its product safety, effectiveness and quality assurance.

EU MDR: from Directive to Regulation

Published on April 5, 2017 and effective on May 26, 2020, the new EU Medical Devices Regulation 2017/745 (MDR) replaces the former European Medical Device Directive 93/42/EEC (MDD) and Council Directive 90/385/EEC on active implantable medical devices (AIMDD), and includes more stringent standards and requirements in surveillance, certification, quality and safety evaluation, corporate compliance and level of technical advances.

This once again demonstrates that MEDA is fully committed to continued innovation and improvements on its quality management system, exemplifies high recognition on MEDA’s product safety and effectiveness, and paves the way for its access to EU and even the global market. MEDA will continue to optimize its quality management system and develop its abilities to adapt to national and regional regulations and standards. With proper guidance and quality assurance of the system, MEDA will be ideally positioned in going global by providing its customers and their patients with medical devices of high safety, effectiveness and reliability.