FDAnews Device Daily Bulletin
Medical Devices / Regulatory Affairs

Italian Company Designated Fourth Notified Body in EU

Aug. 27, 2019

IMQ, an Italian certification firm, has been named the EU’s fourth notified body for certification of devices under the Medical Device Regulations.

IMQ joins BSI Assurance UK, TÜV SÜDand DEKRA as the only NBs that can certify devicemakers for MDR compliance.

With less than one year before the MDR takes effect, 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.

The medical device regulations go into full effect in May 2020.

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