MDR: 19th Notified Body on NANDO!

The NANDO database newly lists 19 Notified Bodies under the MDR!

ISTITUTO SUPERIORE DI SANITA has been notified under the Regulation (EU) 2017/745 on medical devices – MDR.

Viale Regina Elena,299

00161 -Roma

Country : Italy

Phone : +39 06 49906146
Fax : +39 06 4990315

Email :
Website :

Notified Body number : 0373

You can find the full scope of its notification on the following link. Here below, an extract from NANDO:

  • 3. Active non-implantable therapeutic devices and general active non-implantable devices
  • MDA 0301 Active non-implantable devices utilising ionizing radiation
    • Limited to therapeutic cyclotrons and linear accelerators
  • 1. Non-active implants and long term surgically invasive devices
  • 2. Non-active non-implantable devices
  • MDN 1214 General non-active non-implantable devices used in health care and other non-active non-implantable 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, electron beam), dry heat.
  • MDN 1101 Non-active cardiovascular, vascular and neurovascular implants
  • MDS 1001 Devices incorporating medicinal substances
  • MDS 1011 Devices in systems or procedure packs
  • MDS 1012 Products without an intended medical purpose listed in Annex XVI to Regulation (EU) 2017/745

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