MDR: 23 Notified Bodies on NANDO

The NANDO database newly lists 23 Notified Bodies under the MDR!

TUV Rheinland Italia SRL has been the latest NB notified under the Regulation (EU) 2017/745 on medical devices – MDR.

TUV Rheinland Italia SRL
Via Mattei, 3
20010 – Pogliano Milanese (MI)
Country : Italy

Phone : +39 02 9396871
Fax : +39 02 93968723

Email : informazioni@it.tuv.com
Website : www.tuvitalia.com

Notified Body number : 1936

You can find the full scope of its notification on the following link. Below, an extract from NANDO, where conditions are listed :

• Active non-implantable devices for imaging, monitoring and/or diagnosis – MDA 0201 Active non-implantable imaging devices utilising ionizing radiation
  • Excluded Class III Medical Devices
• Active non-implantable devices for imaging, monitoring and/or diagnosis – MDA 0203 Active non-implantable devices for monitoring of vital physiological parameters
  • Excluded, only for annex X and XI B: Transcutaneous partial pressure monitoring equipment, Electroencephalographs, Blood pressure indirect, automatic and periodic measuring equipment, Direct blood pressure monitoring equipment, Multiparametric patient monitors, Medical device for registration and analysis of data from single and multiple channel electrocardiograps, Screening thermographic device for verification of human fever, Electromechanic blood pressure measuring device, Clinical thermometers.
• Active non-implantable therapeutic devices and general active non-implantable devices – MDA 0303 Active non-implantable devices utilising hyperthermia/hypothermia
  • Excluded Class III Medical Devices
• Active non-implantable therapeutic devices and general active non-implantable devices – MDA 0305 Active non-implantable devices for stimulation or inhibition
  • Excluded, only for Annex X and XI B: Neuromuscular stimulators.
• Active non-implantable therapeutic devices and general active non-implantable devices – MDA 0307 Active non-implantable respiratory devices
  • Excluded Class III Medical Devices Excluding hyperbaric chamber Excluded, only for Annex X and XI B: Pulmunary ventilators, Systems for anesthesia, Iperbaric chambers, Device for the respiratory therapy of apnea during sliping, Spirometers.
• Active non-implantable therapeutic devices and general active non-implantable devices – MDA 0308 Active non-implantable devices for wound and skin care
  • Excluded Class III Medical Devices
•  Non-active implants and long term surgically invasive devices- MDN 1101 Non-active cardiovascular, vascular and neurovascular implants.
  • Excluded neurovascular implant
• Non-active non-implantable devices – MDN 1212 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)
  • Excluded Class III Medical Devices Excluded in vitro fertilisation (IVF) and assisted reproductive technologies (ART) 
• 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
• ..

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