MDR: 27 Notified Bodies on NANDO

The NANDO database newly lists 27 Notified Bodies under the MDR!

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

ITALCERT SRL
Viale Sarca, 336
20126 – MILANO
Country : Italy

Phone : +39 02 66104876
Fax : +39 02 66101479

Email : italcert@italcert.it
Website : www.italcert.it

Notified Body number : 0426

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

• MDA 0315 Software
  
  • Annex IX(I), Annex IX(II), Annex XI(A)
• MDN 1206 Non-active non-implantable ophthalmologic 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 devices for In Vitro Fertilisation (IVF) and Assisted Reproductive Technologies (ART) 
    
• MDS 1001 Devices incorporating medicinal substances
  
  • Excluded human blood or plasma derivatives
• MDS 1003 Devices manufactured utilising tissues or cells of animal origin, or their derivatives
  • Excluded medical devices utilising tissues of animal origin under Commission Regulation (UE) No. 722/2012.
• MDS 1005 Devices in sterile condition
  • Including: – aseptic processing – ethylene oxide gas sterilisation (EOG) – moist heat sterilisation – radiation sterilisation (gamma-ray, x-ray, electron beam) – hydrogen peroxide sterilisation
• MDS 1013 Class III custom-made implantable devices
  • Limited to non-active osteo- and orthopaedic implants, non-active dental implants and dental materials, non-active soft tissue and other implants
• ..

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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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