MDR: 32 Notified Bodies on NANDO

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

BUREAU VERITAS ITALIA S.P.A.
Viale Monza, 347
20126 – MILANO (MI)
Country : Italy

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

Email : info.bv.italia@it.bureauveritas.com
Website : www.bureauveritas.it

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
• …

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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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