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TÜV Nande officially obtained the EU MDR cerification authority
May 22, 2019
China/Shanghai, May 22, 2019, TÜV SÜD (NB 0123) (hereinafter referred to as “TÜV Nande”), a third-party testing and certification organization from Germany, officially obtained the new EU Medical Device Regulation MDR [REGULATION (EU) 2017/745] Announcement Agency Qualifications. TÜV SÜD Greater China can provide conformity assessment services (CE certification) under the new regulatory framework for Chinese medical device products exported to the EU. The detailed information and authorized product range can be viewed on the EU NANDO website. You can click “Read more” "View.
With more than 150 years of history, TÜV SÜD has a team of nearly 1,000 people in the medical device field, including medical device experts, engineers and clinical experts in various fields. It is the world's leading medical device announcement agency with a global location.
In the past 30 years, the professional and authoritative team of TÜV SÜD Greater China has been committed to escort the “Made in China” medical device products to the international market. TÜV SÜD is able to provide complete testing, auditing and certification services to help Chinese manufacturers control risk and provide localized one-stop services for manufacturers throughout the life of the medical device, including but not limited to product testing, CE technical documentation. Review, on-site audit, risk management and clinical compliance assessment. TÜV SÜD has completed preparations for MDR and will officially open the acceptance of MDR certification applications to help Chinese medical device manufacturers obtain CE certificates under MDR regulations.
About MDR
On May 5, 2017, the EU officially issued the new medical device regulation MDR [REGULATION (EU) 2017/745]. The regulation came into effect on May 25, 2017, replacing the current European Medical Device Directive (93/42/EEC) and the Active Implantable Medical Device Directive (90/385/EEC). As of May 26, 2020, medical device products exported to Europe must meet the requirements of MDR.