Recently, JAMR obtained the MDR CE certificate issued by TÜV SÜD. MDR (EU 2017/745) is a new medical device regulation issued by the EU in May 2017 to replace the former medical device directive MDD (93/42/EEC). The MDR regulation is fully effective as
of 25 May 2021.
The new EU MDR regulation places greater focus on clinical performance, better traceability and greater transparency to patients, presenting greater challenges to medical device manufacturers. Compared to the original MDD Directive, the MDR places higher
demands on product risk management, product performance and safety standards, pre-market clinical evaluation and post-market vigilance and supervision of products.
The issuance of the MDR certificate reflects the high standards and requirements of JAMR on quality, safety, effectiveness and product quality management systems. JAMR will continue to provide high quality health management products to our customers.
