French notified body GMED designated under MDR
France’s GMED on Wednesday became the country’s first notified body designated under the Medical Devices Regulation (MDR) and the 15th overall with less than a year before the regulation’s new date of application.The Paris-based GMED is the sixth to be designated in 2020, following the designation of Swedish notified body Intertek in May. (RELATED: MDR delay official as industry calls to push back IVDR, Regulatory Focus 24 April 2020; Swedish notified body is 14th designated under MDR, Regulatory Focus 15 May 2020).
In a statement on its website, GMED said its designation covers “a field of medical device categories among the broadest,” and includes the ability to conduct conformity assessments for active implantable devices. The company also says it intends to receive designation under the In Vitro Diagnostic Regulation (IVDR), “in the best possible timeframe.”
In addition to its new designation under MDR, GMED is a designated notified body under the previous directives for medical devices, active implantable medical devices and in vitro diagnostics.