FDAnews Device Daily Bulletin
Medical Devices / Regulatory Affairs

European Commission Designates Fifth Notified Body

Sept. 30, 2019

The European Commission designated TÜV Rheinland LGA Products in Nürnberg, Germany as the fifth notified body for certifying devicemakers for compliance with the EU’s Medical Device Regulation.

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

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

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