TUV Rheinland issue first EU MDR certificate for Terumo Corp
YOKOHAMA, Japan, June 10, 2020 /PRNewswire/ -- TUV Rheinland Japan Ltd. announced that on May 29, 2020 TUV Rheinland LGA Products GmbH issued TUV Rheinland's first MDR certificates under EU Medical Device Regulation 2017/745, for medical devices Terumo Corporation.
TUV Rheinland LGA Products GmbH performed a conformity assessment for Terumo in accordance with the new EU MDR requirements. This conformity assessment includes the evaluation of general safety and performance requirements set out in Annex I and relevant Annexes. As a result of conformity assessment by technical documentation review and audit, it was proven that they meet the requirements. TUV Rheinland issued the EC certificate under REGULATION (EU) 2017/745 on Medical Devices, Annex IX Chapter I, Section 2 and 3 and Chapter III.
This is also the first MDR certificate for Terumo Corporation and it includes the following products.
- Hypodermic Needles
- Carpule Needles
- Infusion and Irrigation Disposable Syringes
- Peripheral Intravenous Catheters (I.V. Cannulas)
TUV Rheinland LGA Products GmbH is a notified body for EU Medical Device Regulation (MDR) 2017/745. The MDR came into effect on May 25, 2017 and was to replace Directives 93/42/EEC (MDD) and 90/385/EEC (AIMDD) on May 26, 2020. However, the European Commission, Parliament, and Council decided to postpone the date of application of the MDR by one year (until May 26, 2021) to prevent a shortage or the delayed delivery of major medical devices due to the novel coronavirus pandemic. TUV Rheinland Group is committed to making every effort to help medical device manufacturers achieve business success in the EU market, through conformity assessment and certification services related to the new EU Medical Device Regulation.
About TUV Rheinland:
TUV Rheinland stands for safety and quality in almost all areas of business and life. Founded almost 150 years ago, the company is one of the world's leading testing service providers with more than 21,400 employees and annual revenues of 2.1 billion euros. TUV Rheinland's highly qualified experts test technical systems and products around the world, support innovations in technology and business, train people in numerous professions and certify management systems according to international standards. In doing so, the independent experts generate trust in products as well as processes across global value-adding chains and the flow of commodities. Since 2006, TUV Rheinland has been a member of the United Nations Global Compact to promote sustainability and combat corruption. Website: www.TUV.com
SOURCE TUV Rheinland