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GMED becomes France’s first MDR Notified Body

  • Posted by: inetika
  • Category: GLOBAL NEWS

GMED has been designated as a Notified Body under Regulation (EU) 2017/745, Medical Device Regulation (MDR), by the French National Agency for Medicines and Health Products Safety (ANSM). It is the first for France, and the 15th in total for the MDR.

To complement its MDR designation, GMED states on its website that it “is determined to succeed in the best possible timeframe, its designation under the Regulation (EU) 2017/746 on in vitro diagnostic medical devices.”

GMED has Notified Body designation number CE 0459, and details of the devices for which it is able to carry out its work under the MDR can be found on this Nando web page.