MDR: 24 Notified Bodies on NANDO

The NANDO database newly lists 24 Notified Bodies under the MDR!

CERTIQUALITY S.r.l. has been the latest NB notified under the Regulation (EU) 2017/745 on medical devices – MDR.

Via G. Giardino, 4
20123 – MILANO
Country : Italy

Phone : +39 02 8069171
Fax : +39 02 86465295

Email :
Website :

Notified Body number : 0546

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

  • 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)
    • Exluding devices for in vitro fertilisation (IFV) and assisted reproductive technologies (ART)
  • MDN 1206 Non-active non-implantable ophthalmologic devices
    • Excluded Class III Medical Devices Except those classified in Class III only as incorporating medicinal substances, according to Directive 2001/83/EC and/or utilising biological active coatings and/or materials or being wholly or mainly absorbed
  • MDS 1001 Devices incorporating medicinal substances
    • Excluding plasma and blood derivatives
  • MDT 2013 Devices which have undergone reprocessing
    • Limited to reusable devices which have to undergone reprocessing
  • ..

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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