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.
CERTIQUALITY S.r.l.
Via G. Giardino, 4
20123 – MILANO
Country : Italy
Phone : +39 02 8069171
Fax : +39 02 86465295
Email : certiquality@certiquality.it
Website : www.certiquality.it
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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