European Commission Designates Fifth Notified Body

  • January 30, 2020

TÜV Rheinland joins IMQ, BSI Assurance UK, TÜV SÜD Product Service and DEKRA as the only NBs that can certify device makers for MDR compliance.

European device groups have expressed concern about a shortage of notified bodies to conduct audits and certify device makers in time to comply with the new regulations that go into full effect in May 2020.

REFERENCE:  FDAnews Device Daily Bulletin/Medical Devices/Regulatory Affairs; 30 SEP 2019

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