TOKYO, JAPAN - June 9, 2020 - Terumo Corporation (TSE: 4543) today announced that it received the certificate under EU Medical Devices Regulations (EU-MDR) on May 29. The certificate covers 4 product categories including Nanopass™, a pen needle for the subcutaneous injection of insulin, manufactured at Kofu Factory in Japan. This is the first certificate under EU-MDR not only at Terumo, but also for TÜV Rheinland LGA Products GmbH, a Germany-based EU notified body under EU-MDR, to issue.
To improve clinical safety and create fair market access for manufacturers, the EU-MDR is designed to be more stringent than the Medical Devices Directives (MDD), the previous regulatory framework.
The notified body performed a conformity assessment in accordance with the new EU-MDR requirements. This includes the evaluation of general safety and performance requirements. As a result of the assessment by technical documentation review and audit, they proved that Terumo meets the requirements and issued the certificate.
Terumo received the certificate ahead of other manufactures, while every medical device company has proceeded actions to meet the requirements of EU-MDR which came into effect in 2017. The company will further accelerate to acquire certifications and to strengthen its operation to deliver safe medical devices worldwide.
- Hypodermic Needles
- Carpule Needles
- Infusion and Irrigation Disposable Syringes
- Peripheral Intravenous Catheters (I.V. Cannulas)
Terumo (TSE: 4543) is a global leader in medical technology and has been committed to “Contributing to Society through Healthcare” for 100 years. Based in Tokyo and operating globally, Terumo employs more than 28,000 associates worldwide to provide innovative medical solutions in more than 160 countries and regions. The company started as a Japanese thermometer manufacturer, and has been supporting healthcare ever since. Now, its extensive business portfolio ranges from vascular intervention and cardio-surgical solutions, blood transfusion and cell therapy technology, to medical products essential for daily clinical practice such as transfusion systems, diabetes care, and peritoneal dialysis treatments. Terumo will further strive to be of value to patients, medical professionals, and society at large.
Corporate Communication Dept., Terumo Corporation