TÜV SÜD Officially Obtained EU MDR Notify Body Qualification

time:2019-05-31 13:36:00  Author:  Source:

  On May 22, 2019, Technischer Überwachungs-Verein SÜD (NB 0123) ( “TÜV SÜD”, Technical Inspection Association) a third-party testing and certification organization from Germany, officially obtained the new EU Medical Device Regulation MDR [REGULATION (EU) 2017/745] Notify Body Qualification in Shanghai, China. 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.

  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 Notify Body 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 medical device products“Made in China”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. 

  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. 


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