FDAnews Device Daily Bulletin
Medical Devices / Regulatory Affairs

TÜV SÜD Gains Second EU MDR Designation

May 29, 2019

TÜV SÜD Product Service has become the second notified body to be accredited under the EU’s new medical device regulation (MDR), meaning the product certifier is now authorized to provide certification services under the new MDR.

European device groups such as the European Association for Medical Devices of Notified Bodies (Team-NB) are alarmed at the shortage of notified bodies to conduct audits and certify devicemakers in time to comply with the new regulations. In January, Team-NB said the May 2017 to May 2020 implementation period was too short, given that many details for both manufacturers and notified bodies are still under discussion.

In April, MedTech Europe warned that the EU’s new regulatory system for devices won’t be ready on time.

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