TÜV Rheinland Japan Ltd. announced that on May 29, 2020 TÜV Rheinland LGA Products GmbH issued TÜV Rheinland's first MDR certificate under EU Medical Device Regulation 2017/745, for medical devices Terumo Corporation.
TÜV 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. TÜV 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 certificates for Terumo Corporation and it includes the following products.
- Hypodermic Needles
- Carpule Needles
- Infusion and Irrigation Disposable Syringes
- Peripheral Intravenous Catheters (I.V. Cannulas)
TÜV 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. TÜV 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.