MDR: 32 Notified Bodies on NANDO

The NANDO database newly listed 32 Notified Bodies under the MDR!

Viale Monza, 347
20126 – MILANO (MI)
Country : Italy

Phone : +39 02 270911
Fax : +39 02 2552980

Email :
Website :

Notified Body number : 1370

You can find the full scope of its notification on the following link.

Below, an extract from NANDO, where conditions/limitations are listed:

  • MDA 0302 Active non-implantable devices utilising non-ionizing radiation
    • Excluded Class III Medical Devices
  • MDA 0307 Active non-implantable respiratory devices
    • Excluding hyperbaric chamber
  • MDA 0315 Software
    • Excluded Class III Medical Devices
  • MDN 1103 Non-active dental implants and dental materials
    • Excluded Class III Medical Devices
  • MDN 1202 Non-active non-implantable devices for administration, channelling and removal of substances, including devices for dialysis
    • Excluded Class III Medical Devices
  • MDN 1203 Non-active non-implantable guide catheters, balloon catheters, guidewires, introducers, filters, and related tools
    • Excluded Class III Medical Devices
  • MDS 1005 Devices in sterile condition
    • Including: – aseptic processing – ethylene oxide gas sterilisation (EOG) – low temperature steam – moist heat sterilisation – radiation sterilisation (gamma-ray, x-ray, electron beam)
  • MDT 2013 Devices which have undergone reprocessing
    • Limited to reusable devices which have to undergone reprocessing

Under the designation scope without limitations:

  • MDA 0201 Active non-implantable imaging devices utilising ionizing radiation
  • MDA 0203 Active non-implantable devices for monitoring of vital physiological parameters
  • MDA 0204 Other active non-implantable devices for monitoring and/or diagnosis
  • MDA 0303 Active non-implantable devices utilising hyperthermia/hypothermia
  • MDA 0305 Active non-implantable devices for stimulation or inhibition
  • MDA 0313 Active non-implantable prostheses, devices for rehabilitation and devices for patient positioning and transport
  • MDA 0317 Active non-implantable devices for cleaning, disinfection and sterilisation
  • MDN 1204 Non-active non-implantable devices for wound and skin care
  • MDN 1205 Non-active non-implantable orthopaedic and rehabilitation devices
  • MDN 1209 Non-active non-implantable dental materials
  • MDS 1012 Products without an intended medical purpose listed in Annex XVI to Regulation (EU) 2017/745

Have a look at the Analysis of NB Designation prepared by our partners AKRA TEAM. You will find it in our dedicated Library of Documents – Notified Body: MDR and IVDR.

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