The French notified body GMED (number 0459) has just been designated in accordance with the MDR ! It is the 15th notified body to successfully pass the designation milestone.

Its designation perimeter is among the most expanded. It is available on the NANDO database of the European Commission, here:

nexialist brings you a round-up of the types of devices not covered by the designation:

  • Active non-implantable devices utilising hyperthermia/hypothermia (MDA 0303)
  • Active non-implantable devices for shock-wave therapy (lithotripsy) (MDA 0304)
  • Non-active non-implantable devices for processing and preservation of human cells, tissue or organs including in vitro fertilisation (IVF) and assisted reproductive technologies (ART) (MDN 1212)
  • Active non-implantable devices for cleaning, disinfection and sterilisation (MDA 0317)
  • Non-active non-implantable devices used for contraception or prevention of the transmission of sexually transmitted diseases (MDN 1210)
  • Devices manufactured utilising tissues or cells of human origin, or their derivatives (MDS 1002)

If the GMED has not yet been designated in application of the IVDR, it will be coming soon!

Need help complying with the MDR? Contact us!